Back to resultsRadiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TraceIT Tissue Spacer implantation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Radiotherapy, Radiation, SBRT
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
- 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
- Hemoglobin: ≥ 8.0 g/dl
- Zubrod Performance Status 0-2
- 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.
- Life expectancy of at least 9 months
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.
- 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.
Sites / Locations
- Johns Hopkins Medicine
- Massachusetts General Hospital
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TraceIT Tissue Spacer
Arm Description
Outcomes
Primary Outcome Measures
Safety Endpoint
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
Secondary Outcome Measures
Radio-Therapy Benefits of TraceIT
Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.
Feasibility of TraceIT
Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).
TraceIT Persistence (at 6-months Post-treatment)
Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.
Theoretical Dose Escalation From Post-TraceIT Treatment Plan
Maximum dose to the GTV while maintaining duodenal dose constraints
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing
Number of subject with Duodenal AE summarized by CTCAE grade and timing
Incidence of Resection Following the Completion of Radiation Therapy (RT)
Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).
Progression Free and Overall Survival
Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)
The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Full Information
NCT ID
NCT03998566
First Posted
June 13, 2019
Last Updated
February 22, 2023
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03998566
Brief Title
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Radiotherapy, Radiation, SBRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TraceIT Tissue Spacer
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TraceIT Tissue Spacer implantation
Intervention Description
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 Measure Information:
Title
Safety Endpoint
Description
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
Time Frame
2-6 week assessment post-procedure
Secondary Outcome Measure Information:
Title
Radio-Therapy Benefits of TraceIT
Description
Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.
Time Frame
2-6 week assessment
Title
Feasibility of TraceIT
Description
Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).
Time Frame
2-6 week assessment post-procedure
Title
TraceIT Persistence (at 6-months Post-treatment)
Description
Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.
Time Frame
2-6 weeks and 6 month post procedure
Title
Theoretical Dose Escalation From Post-TraceIT Treatment Plan
Description
Maximum dose to the GTV while maintaining duodenal dose constraints
Time Frame
2-6 week assessment Post-procedure
Title
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing
Description
Number of subject with Duodenal AE summarized by CTCAE grade and timing
Time Frame
18 months post procedure
Title
Incidence of Resection Following the Completion of Radiation Therapy (RT)
Description
Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).
Time Frame
2-6 weeks post procedure
Title
Progression Free and Overall Survival
Description
Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.
Time Frame
18 months post procedure
Title
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)
Description
The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Time Frame
Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month
Other Pre-specified Outcome Measures:
Title
Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel
Description
Scores for the visualization of the fiducial marker and TraceIT hydrogel.
Time Frame
2-5 weeks assessment post procedure
Title
TraceIT Stability and Space Measurements
Description
The stability of TraceIT was measured as the minimum distance from the fiducial marker to TraceIT gel. Space measurements were taken before and after TraceIT was injected, which measured the preduodenal space using the axial view along the head of the HOP.
Time Frame
Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy
Title
Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26
Description
The QLQ-PAN26 questionnaire is a survey designed to assess patient-reported symptoms of patients undergoing treatment for pancreatic cancer. All of the scales and single item measures range in score from 0-100. A high score for the symptom scales and/or single items represents a high level of symptomatology or problems, whereas a high score for the functional scales represents a high level of functioning.
Time Frame
Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Hemoglobin: ≥ 8.0 g/dl
Zubrod Performance Status 0-2
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.
Life expectancy of at least 9 months
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.
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.
Facility Information:
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
We'll reach out to this number within 24 hrs