Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

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: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: TraceIT Tissue Spacer implantation

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	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

Outcome Measure	Measure Description	Time Frame
Radio-Therapy Benefits of TraceIT	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	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)	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	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	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)	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	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)	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

Outcome Measure	Measure Description	Time Frame
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel	Scores for the visualization of the fiducial marker and TraceIT hydrogel.	2-5 weeks assessment post procedure
TraceIT Stability and Space Measurements	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	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

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; SBRT; Radiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID 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