Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

NCT03998566 | Completed Results FDA Device

• 1 other identifier: AGX17-001-US
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatic Cancer

Keywords

Radiotherapy; Radiation; SBRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing

  18 months post procedure

Other Outcomes (3)

• Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel

  2-5 weeks assessment post procedure

• TraceIT Stability and Space Measurements

  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

  Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26

Study Arms (1)

TraceIT Tissue Spacer

EXPERIMENTAL

Device: TraceIT Tissue Spacer implantation

Interventions

TraceIT Tissue Spacer implantation DEVICE

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.

TraceIT Tissue Spacer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jeya Satheesh
• Organization: Boston Scientific

jeya.satheesh@bsci.com

6124490870

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 26, 2019
• Study Start: April 24, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 27, 2023
• Results First Posted: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)