Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable… (NCT07325214) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer
United States, South Korea136 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* An individual must meet all the following criteria:
* 1\. Willing and able to understand and sign an ICF and to comply with all aspects of the protocol
* 2\. Aged between 18 and 85 years, inclusive
* 3\. Histologically or cytologically, pathologically confirmed diagnosis of PDAC.
* 4\. Classification as BRPC or LAPC according to the NCCN Guidelines (The latest Edition) by radiologic test (CT or MRI), eligible for chemotherapy regimen within 4 weeks of the screening visit
* 5\. Must have at least 1 measurable lesion per RECIST 1.1 criteria at the screening visit.
* 6\. The ECOG performance status 0 or 1
* 7\. Trial participant having laboratory values defined as: Neutrophil count ≥ 1.5 x 10\^9/L, Platelet count ≥ 100 x 10\^9/L, AST and ALT ≤ 2.5 x ULN, - Serum creatinine ≤ 1.5 x ULN
* 8\. Life expectancy is more than 12 weeks
* 9\. A female is eligible to trial participate if not pregnant, not breast feeding and either a woman not of childbearing potential or, if a woman of childbearing potential agrees to use highly effective methods of contraception\* from screening to EOS
* 10\. A male trial participant with female partner(s) of childbearing potential agrees to use highly effective methods of contraception from screening to EOS
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participating in this clinical trial:
* 1\. The presence of a cystic lesion within tumor to be treated, or at the pancreas adja…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: From the date of the first trial participant's randomization to 24 months after the last trial participant's randomization