Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

NCT ID: NCT03998566

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2021-05-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TraceIT Tissue Spacer

Group Type: EXPERIMENTAL

TraceIT Tissue Spacer implantation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AGX17-001-US

Identifier Type: -

Identifier Source: org_study_id