Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

June 16, 2026 updated by: GE Healthcare

A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study.

The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska Universitetssjukhuset
  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Not yet recruiting
        • BAMF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is ≥18 years of age
  • Participant has provided signed informed consent before any study-specific screening procedures
  • Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
  • Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.
  • Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET/CT Imaging Visit
  • Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Participant is able and willing to comply with all study procedures as described in the protocol

Exclusion Criteria:

  • Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP)
  • Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
  • Participant needs any intervention that would delay study participation
  • Participant has non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work up
  • Participant will not be able to complete the study, based on their anticipated life expectancy
  • Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)

  • Participant has renal function impairment as defined by:

    1. For Phase 2: estimated glomerular filtration rate less than 60 mL/min
    2. For Phase 3: estimated glomerular filtration rate less than 30 mL/min

  • Participant has severe hepatic function impairment as defined by:

    1. Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) and alanine aminotransferase (serum glutamic-pyruvic transaminase): ≤2.5 × upper limit of normal (ULN; ≤5 × ULN for participants with liver metastases)
    2. Bilirubin: ≤1.5 × ULN or direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
  • Participant has autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and/or protocol objectives
  • Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)
  • Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)
  • Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET/CT scan for any reason
  • (Phase 3 only) Participant was previously included in Phase 2 of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GEH300079 (68Ga) PET/CT Injection
Single IV bolus of GEH300079 (68Ga), target activity 3.6 MBq/kg (150-300 MBq). PET/CT scan at 60 ±5 min post-dose (vertex to mid-thigh, ~20-30 min). Phase 2 subset: additional scans at 15 ±5 min and 3 h ±10 min.
Drug: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
Attenuation correction CT will commence after the administration of GEH300079 (68Ga), and immediately before the PET acquisition. The PET acquisition will encompass the participant's vertex through mid-thighs. Images will be acquired at 60 ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC.
Time Frame: Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
The co-primary efficacy endpoint is based on region level sensitivity and specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC in participants with colorectal, gastric or ovarian primary cancer. GEH300079 (68Ga) PET/CT images collected during the Phase 2 part will be reviewed by 5 independent readers. Images collected during the Phase 3 part will be reviewed by 3 readers. The superiority of per region sensitivity (respectively specificity) to a pre-specified threshold of 75% (respectively 70%) will be assessed using one-sided Z-tests. The co-primary endpoints will be considered as met if superiority of both per region sensitivity and per region specificity is achieved by at least 3 of the 5 readers in the Phase 2 part, and by at least 2 of the 3 readers in the Phase 3 part.
Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging and non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging.
Time Frame: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.

Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to SoC imaging will be assessed on participants from the ITI using a McNemar test.

Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to SoC imaging, will be assessed using a restricted maximum likelihood estimate (RMLE) -based score test, with a non-inferiority margin of 10%.

SoC images will be reviewed by 3 independent readers. The co-key secondary endpoints will be met if the co-primary endpoints are met and both co-key secondary endpoints are demonstrated for the same reader, for at least 2 of the 3 pairs of readers.
Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging in Phase 3
Time Frame: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging will be assessed using a McNemar test, in the Phase 3 part.
Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC
Time Frame: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC will be tabulated.
Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Correlation between radiological and surgical/laparoscopic PCI scores
Time Frame: Single time point. Baseline SoC images. GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
Correlation between radiological PCI scores (based on GEH300079 (68Ga) PET/CT, CT, MR, [18F]FDG PET/CT) and surgical/laparoscopic PCI score.
Single time point. Baseline SoC images. GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
The number of Positive peritoneal regions and percentage of participants with a difference in the number of Positive peritoneal regions.
Time Frame: single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
The number of Positive peritoneal regions identified by GEH300079 (68Ga) PET/CT, CT, MR, and [18F]FDG PET/CT, and the percentage of participants with a difference in the number of Positive peritoneal regions identified by GEH300079 (68Ga) PET/CT and baseline SoC imaging.
single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmax of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time Frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmax of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmean of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time Frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmean of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVpeak of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time Frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVpeak of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Tumor to-background ratio (TBR) of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time Frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
TBR of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Contrast-to-noise ratio (CNR) of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time Frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
CNR of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Correlation between FAP expression and GEH300079 (68Ga) PET/CT uptake in PC from different primary cancer in Phase 2
Time Frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
The correlation between GEH300079 (68Ga) PET/CT uptake in PC from different primary cancers and FAP expression measured by IHC in Phase 2.
Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
Percentage of participants for whom GEH300079 (68Ga) PET/CT could have led to a change in treatment plan
Time Frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Percentage of locoregional to systemic (M0 to M1) upstaging induced by GEH300079 (68Ga) PET/CT
Time Frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
GEH300079 (68Ga) PET/CT image quality at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time Frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Visual assessment score of overall image quality at 15 ±5 minutes, 60 ±5 minutes, and 3 hours ±10 minutes post-injection, and across different simulated injected activities
GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Tumor to-background ratio (TBR) of GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities
Time Frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
TBR for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Contrast-to-noise ratio (CNR) of GEH300079 (68Ga) PET/CT TBR at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time Frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
CNR for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Number of lesions detected by GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time Frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Count of lesions (<2 cm, ≥2 cm) for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Size of lesions detected by GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time Frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Size of lesions for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Coefficient of Variation (CV) of GEH300079 (68Ga) PET/CT SUV in Background and Reference Tissues at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time Frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Variation coefficient of SUV in local background and reference tissues for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Intra-reader reproducibility for GEH300079 (68Ga) PET/CT
Time Frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Cohen's kappa statistics with 95% CI for read vs re-read, for each of the readers.
Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Inter-reader agreement for GEH300079 (68Ga) PET/CT
Time Frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Cohen's kappa statistics with 95% CI for the assessment of agreement between 2 readers. Fleiss's kappa statistics with 95% CI will be provided for the assessment across the readers.
Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GE Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fortrea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GE-282-201
  • IND:151901 (Other Identifier: US FDA)
  • 2024-519384-18-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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