Testing focused ultrasound with chemotherapy for pancreatic cancer that cannot yet be removed
Tests focused ultrasound with chemotherapy in adults with locally advanced pancreatic cancer.
Plain-language title generated from the registry record
Registry title: Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer
Key facts
- Where
- Boston, Charlottesville, and San Antonio, United StatesSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07325214, who can take part
Where in United States
- Brigham and Women's HospitalBoston, United StatesNot yet recruiting
- University of Virginia Medical CenterCharlottesville, United StatesTaking people
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IMGT Co., Ltd.
- Trial code
- NCT07325214
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Multicenter, Multiregional, Pivotal Clinical Trial to Evaluate the Safety and Efficacy of IMD10 (Focused Ultrasound) in Combination With the Chemotherapy Regimen Consisting of Irinotecan Hydrochloride, Oxaliplatin, Fluorouracil (5-FU) and Leucovorin Improves Overall Survival Compared With the Chemotherapy Regimen Alone in Patients With Borderline Resectable Pancreatic Cancer or Locally Advanced Pancreatic Cancer
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.
Inclusion: 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 109/L; Platelet count ≥ 100 x 109/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: 2. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass; 13. Participating in another drug/device clinical trial or have participated in another drug/device clinical trial within 4 weeks of C1D1; 6. Known history of severe hypersensitivity to ultrasound gel or to chemotherapies (irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin) used in this clinical trial; 7. Known, or ongoing receipt at the time of screening, of anti-tumor therapy for pancreatic cancer including chemotherapy, radiation, and/or surgery; 8. A cardiovascular condition at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:; Class III or IV heart failure according to New York Heart Association (NYHA) classification; Acute coronary syndrome (unstable angina or myocardial infarction) within the last 24 weeks --③ Uncontrolled heart arrhythmia; Other clinically significant cardiovascular abnormalities as determined by the investigator; 9. Known history at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:; Other uncontrolled chronic infectious diseases; Active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.); Congenital or acquired immunodeficiency diseases, such as cellular immunodeficiency, hypogammaglobulinemia, and hypergammaglobulinemia; Clinically significant mental illness; 10. Known history of malignancies other than pancreatic cancer within the last 2 years; 11. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1); 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 adjacent to the treated tumor; 3. Targeted tumor(s) is not clearly visible with IMD10; 4. Tumor is not treatable by the working range of IMD10; 5. Patient has difficulty in lying in supine position; 12. Pregnant and breastfeeding women; 14. Trial participation in the clinical trial is deemed inappropriate at the investigator's discretion, either for ethical reasons or due to potential impact on the clinical trial's outcome.