Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: TraceIT Tissue Spacer implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines 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. Subject is able to comply with motion management guidelines. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: White blood cell count: ≥ 3.0 x 109/L Absolute neutrophil count (ANC): ≥ 1.5 x 109/L Platelets: ≥ 100 x 109/L Total bilirubin: ≤ 2.0 times upper limit of normal (ULN) AST and ALT: ≤ 3.0 times institutional upper normal limit Serum creatinine: < 1.5 times ULN e INR: < 1.5 Serum pregnancy: Negative Hemoglobin: ≥ 8.0 g/dl Zubrod Performance Status 0-2 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. Life expectancy of at least 9 months Exclusion Criteria: Patients for whom radiotherapy is contraindicated Previous thoracic or abdominal radiotherapy Any GI abnormality that would interfere with the ability to access the injection site Presence of tumor invasion of the duodenum detected on EUS at time of biopsy Previous Whipple procedure or other resection of pancreatic tumor prior to screening Active gastroduodenal ulcer or uncontrolled watery diarrhea History of Chronic Renal Failure. 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) Currently enrolled in another investigational drug or device trial that clinically interferes with this study. Unable to comply with the study requirements or follow-up schedule. 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. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TraceIT Tissue Spacer<br> | Device: TraceIT Tissue Spacer implantation<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Radiation, SBRT