$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

2019-04-24

2021-05-01

2021-05-01

6

Study Overview

Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

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.

N/A

  • Pancreatic Cancer
  • DEVICE: TraceIT Tissue Spacer implantation
  • AGX17-001-US

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 Registration Dates Results Reporting Dates Study Record Updates

2019-06-13  

2022-04-18  

2023-02-22  

2019-06-24  

2023-02-22  

2023-02-27  

2019-06-26  

2023-02-27  

2023-02  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety EndpointNumber 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 MeasuresMeasure DescriptionTime Frame
Radio-Therapy Benefits of TraceITNumber 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 TraceITNumber 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)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 PlanMaximum dose to the GTV while maintaining duodenal dose constraints2-6 week assessment Post-procedure
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and TimingNumber of subject with Duodenal AE summarized by CTCAE grade and timing18 months post procedure
Incidence of Resection Following the Completion of Radiation Therapy (RT)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 SurvivalProgression-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)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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

NPCF Pop up

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate