Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- IMGT Co., Ltd.
- Study ID
- NCT07325214
- Status
- Not Yet Recruiting
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Conditions
- Borderline Resectable Pancreatic Cancer
- Locally Advanced Pancreatic Cancer
- Pancreatic Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- IMD10 — DEVICEA non-thermal/non-tissue destructive Focused Ultrasound (FUS) device
- chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] — DRUGChemotherapy regimen consisting of irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin
Study Details
The purpose of this Interventional clinical trial is to evaluate safety and efficacy of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Jan 2026
- Primary completion
- Aug 31, 2029
- Completion
- Aug 31, 2029
Study Design
- Enrollment
- 136 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental groupThe experimental group receives chemotherapy regimen \[irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin\] in combination with IMD10.
- Active Comparator: Control groupThe control group receives a chemotherapy regimen \[irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin\] alone, the same regimen administered to the experimental group.
Primary Outcome Measure
Overall Survival [ Time Frame: From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization ]
Central Contacts
- Jeongmin Jang, Clinical Team+82-70-5080-2438
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Jiping Wang, M.D. |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | Richard Tuli, M.D. |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | Allan Tsung, M.D. |
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