Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

February 22, 2023 updated by: Boston Scientific Corporation

Early Feasibility Study For Evaluation Of The TraceIT® Tissue Spacer For Creating Space Between The Duodenum And Pancreas In Patients With Localized Pancreatic Cancer Undergoing Radiation Therapy

An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.

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.

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.
6

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
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
  3. Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.
  4. Subject is able to comply with motion management guidelines.
  5. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
  6. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.

  7. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:

    1. White blood cell count: ≥ 3.0 x 109/L
    2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
    3. Platelets: ≥ 100 x 109/L
    4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
    5. AST and ALT: ≤ 3.0 times institutional upper normal limit
    6. Serum creatinine: < 1.5 times ULN e
    7. INR: < 1.5
    8. Serum pregnancy: Negative
    9. Hemoglobin: ≥ 8.0 g/dl
  8. Zubrod Performance Status 0-2
  9. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
  10. Life expectancy of at least 9 months

Exclusion Criteria:

  1. Patients for whom radiotherapy is contraindicated
  2. Previous thoracic or abdominal radiotherapy
  3. Any GI abnormality that would interfere with the ability to access the injection site
  4. Presence of tumor invasion of the duodenum detected on EUS at time of biopsy
  5. Previous Whipple procedure or other resection of pancreatic tumor prior to screening
  6. Active gastroduodenal ulcer or uncontrolled watery diarrhea
  7. History of Chronic Renal Failure.
  8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)
  9. Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
  10. Unable to comply with the study requirements or follow-up schedule.
  11. Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.
  12. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.

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: Treatment
  • 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: TraceIT Tissue Spacer
Device: TraceIT Tissue Spacer implantation
The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.

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
Safety Endpoint
Time Frame: 2-6 week assessment post-procedure
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
2-6 week assessment post-procedure

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
Radio-Therapy Benefits of TraceIT
Time Frame: 2-6 week assessment
Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.
2-6 week assessment
Feasibility of TraceIT
Time Frame: 2-6 week assessment post-procedure
Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).
2-6 week assessment post-procedure
TraceIT Persistence (at 6-months Post-treatment)
Time Frame: 2-6 weeks and 6 month post procedure
Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.
2-6 weeks and 6 month post procedure
Theoretical Dose Escalation From Post-TraceIT Treatment Plan
Time Frame: 2-6 week assessment Post-procedure
Maximum dose to the GTV while maintaining duodenal dose constraints
2-6 week assessment Post-procedure
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing
Time Frame: 18 months post procedure
Number of subject with Duodenal AE summarized by CTCAE grade and timing
18 months post procedure
Incidence of Resection Following the Completion of Radiation Therapy (RT)
Time Frame: 2-6 weeks post procedure
Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).
2-6 weeks post procedure
Progression Free and Overall Survival
Time Frame: 18 months post procedure
Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.
18 months post procedure
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)
Time Frame: Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month
The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel
Time Frame: 2-5 weeks assessment post procedure
Scores for the visualization of the fiducial marker and TraceIT hydrogel.
2-5 weeks assessment post procedure
TraceIT Stability and Space Measurements
Time Frame: Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy
The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.
Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26
Time Frame: Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26
The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning.
Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26

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.
Boston Scientific Corporation

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.
April 24, 2019

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.
May 1, 2021

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.
May 1, 2021

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).
June 13, 2019

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 24, 2019

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.
June 26, 2019

Study Record Updates

Last Update Posted (Estimate)

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.
February 27, 2023

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.
February 22, 2023

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.
February 1, 2023

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.
  • AGX17-001-US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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