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Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03998566
Recruitment Status : Active, not recruiting
First Posted : June 26, 2019
Last Update Posted : October 11, 2019
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: TraceIT Tissue Spacer implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. The ability to place TraceIT Tissue Spacer and create space between the duodenum and head of pancreas in patients undergoing image-guided radiotherapy for pancreatic adenocarcinoma. [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03998566

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United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Boston Scientific Corporation

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Responsible Party: Boston Scientific Corporation Identifier: NCT03998566     History of Changes
Other Study ID Numbers: AgX17-001-US
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Boston Scientific Corporation:
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents