Pancreatic CancerNCT03998566
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
A study testing TraceIT Tissue Spacer implantation in people with Pancreatic Cancer, run by Boston Scientific Corporation at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- TraceIT Tissue Spacer implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Apr 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02215
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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
- Being tested
- TraceIT Tissue Spacer implantation
- Keywords
- Radiotherapy, Radiation, SBRT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraceIT Tissue Spacer implantationDevice
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 group | Role | What they receive |
|---|---|---|
| TraceIT Tissue Spacer | Experimental | Not described Receives: Device: TraceIT Tissue Spacer implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
Measured: 2-6 week assessment post-procedure
Secondary outcomes (8)
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.
Measured: 2-6 week assessment
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).
Measured: 2-6 week assessment post-procedure
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.
Measured: 2-6 weeks and 6 month post procedure
Theoretical Dose Escalation From Post-TraceIT Treatment Plan
Maximum dose to the GTV while maintaining duodenal dose constraints
Measured: 2-6 week assessment Post-procedure
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
Measured: 18 months post procedure
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).
Measured: 2-6 weeks post procedure
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.
Measured: 18 months post procedure
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.
Measured: Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start24 Apr 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998566
- Sponsor's protocol ID
- AGX17-001-US
- Status last verified
- Feb 2023
- First submitted
- 13 Jun 2019
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03998566
- Acronym / sponsor ID
- AGX17-001-US
- Conditions
- Pancreatic Cancer
- Keywords
- Radiotherapy, Radiation, SBRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TraceIT Tissue Spacer | Experimental | Device: TraceIT Tissue Spacer implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TraceIT Tissue Spacer implantationThe TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care. | Device | TraceIT Tissue Spacer |
Primary outcome
Safety Endpoint
Time frame: 2-6 week assessment post-procedure
Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).
8 secondary outcomes
Radio-Therapy Benefits of TraceIT
Time frame: 2-6 week assessment
Feasibility of TraceIT
Time frame: 2-6 week assessment post-procedure
TraceIT Persistence (at 6-months Post-treatment)
Time frame: 2-6 weeks and 6 month post procedure
Theoretical Dose Escalation From Post-TraceIT Treatment Plan
Time frame: 2-6 week assessment Post-procedure
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing
Time frame: 18 months post procedure
Incidence of Resection Following the Completion of Radiation Therapy (RT)
Time frame: 2-6 weeks post procedure
Progression Free and Overall Survival
Time frame: 18 months post procedure
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)
Time frame: Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TraceIT Tissue Spacer implantation in people with Pancreatic Cancer, run by Boston Scientific Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: 2-6 week assessment post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.