About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

1. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor.

2. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass

3. Targeted tumor(s) is not clearly visible with IMD10.

4. Tumor is not treatable by the working range of IMD10

Trial design

Treatments tested in this trial

  • IMD10
  • chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]

Treatment groups

136 Participants
are divided into 2 treatment groups

Locations

5
South Korea
Seoul National University Bundang Hospital,13620, Gyeonggi-do South Korea
Seoul National University Hospital03080, Seoul South Korea
United States
Brigham and Women's Hospital02115, BostonMassachusetts, United States
University of Texas Health Science Center at San Antonio78229, San AntonioTexas, United States

Sponsors and collaborators

IMGT Co., Ltd.

Lead sponsor