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出境医 / 临床实验 / Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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
Actual Primary Completion Date : May 1, 2021
Actual Study Completion Date : May 1, 2021
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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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
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE October 5, 2018
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019) 		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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: TraceIT Tissue Spacer
Intervention: Device: TraceIT Tissue Spacer implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2019) 		6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2021
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998566
Other Study ID Numbers  ICMJE AGX17-001-US
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boston Scientific Corporation
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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