68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)

August 4, 2025 updated by: Ebrahim Delpassand, Radio Isotope Therapy of America

An Open-label, Single-dose, Clinical Trial of 68Ga-DOTATATE (GalioMedix™) PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.

Study Overview

Status

Status

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

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.

Detailed Description

The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.

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 (Actual)

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.
169

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.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77042
        • Radio- Isotope Therapy of America

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Subjects of either sex, aged ≥18 years
  • Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day
  • Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN [ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively], Bilirubin: ≤3 times ULN [ULN for total bilirubin is 1.3mg/dL]
  • Serum creatinine: Serum creatinine: <170 μmol/L
  • egative pregnancy test in women capable of child-bearing

Exclusion Criteria:

  • Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug
  • Pregnant or breast-feeding women
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the 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: 68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
Drug: 68Ga-DOTATATE
68Ga-DOTATATE (3-5 mCi ±25%; 111-185 MBq) is administered as a single intravenous bolus injection in each participant. These injections were performed within 28 days after the Octreoscan.
Other Names:
  • Gallium-68 DOTATATE
  • [⁶⁸Ga]-DOTA-Tyr3-Octreotate
  • 68Ga DOTA-TATE
Diagnostic test: PET/CT
68Ga-DOTATATE PET images will be acquired 60 ±30 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET images were performed within 28 days after the Octreoscan.
Other Names:
  • PET-CT Scan
Diagnostic test: 111In-pentetreotide OctreoScan
OctreoScan™ was performed after intravenous injection of 111In-pentetreotide, a radiopharmaceutical that binds to somatostatin receptors, if the patient had not undergone such imaging as a standard of care. Subsequent planar and/or SPECT imaging was used to detect somatostatin receptor-positive lesions.
Diagnostic test: MRI
MRI (Standard of Care)
Other Names:
  • Magnetic Resonance Imaging (MRI)

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
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
Time Frame: SOT within 28 days before 68Ga-DOTATATE PET/CT scan
We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
SOT within 28 days before 68Ga-DOTATATE PET/CT scan

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
Frequency and severity of Adverse Events
Time Frame: 4 days
Adverse events will be collected from the time of 68Ga-DOTATATE injection until 48 hours post-injection visit. Adverse events will be classified using criteria for adverse events (CTCAE) Version 4.
4 days

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.
Radio Isotope Therapy of America

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.
Excel Diagnostics and Nuclear Oncology Center
Radiomedix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebrahim Delpassand, MD, Radiomedix, Inc.

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 (Actual)

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.
March 1, 2013

Primary Completion (Actual)

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.
December 30, 2015

Study Completion (Actual)

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.
December 5, 2017

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).
April 11, 2013

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.
June 13, 2013

First Posted (Estimated)

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.
June 18, 2013

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.
August 6, 2025

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.
August 4, 2025

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.
August 1, 2025

More Information

Terms related to this study

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.
  • 117289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings