Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998566
• Other study ID #: AGX17-001-US
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel	Scores for the visualization of the fiducial marker and TraceIT hydrogel.	2-5 weeks assessment post procedure
Other	TraceIT Stability and Space Measurements	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.	Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy
Other	Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26	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.	Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26
Primary	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	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.	2-6 week assessment
Secondary	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).	2-6 week assessment post-procedure
Secondary	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.	2-6 weeks and 6 month post procedure
Secondary	Theoretical Dose Escalation From Post-TraceIT Treatment Plan	Maximum dose to the GTV while maintaining duodenal dose constraints	2-6 week assessment Post-procedure
Secondary	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	18 months post procedure
Secondary	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).	2-6 weeks post procedure
Secondary	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.	18 months post procedure
Secondary	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.	Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month