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

Boston Scientific Corporation3 sites in 1 country6 target enrollmentApril 24, 2019

ConditionsPancreatic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: Boston Scientific Corporation
Enrollment: 6
Locations: 3
Primary Endpoint: Safety Endpoint
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 24, 2019

End Date

May 1, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Progression Free and Overall Survival(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)(Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month)
Radio-Therapy Benefits of TraceIT(2-6 week assessment)
Feasibility of TraceIT(2-6 week assessment post-procedure)
TraceIT Persistence (at 6-months Post-treatment)(2-6 weeks and 6 month post procedure)
Theoretical Dose Escalation From Post-TraceIT Treatment Plan(2-6 week assessment Post-procedure)
Incidence of Resection Following the Completion of Radiation Therapy (RT)(2-6 weeks post procedure)
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing(18 months post procedure)