Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer (NCT04821284) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer
United States, Norway120 participantsStarted 2021-12-06
Plain-language summary
This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer. Sonoporation is a novel method that uses ultrasound and microbubbles to increase therapeutic effect by increasing uptake or enhance sensitization. Sonoporation together with chemotherapy may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be \>= 18 years old
* Patient has a new diagnosis of PDAC and is scheduled to undergo SoC chemotherapy
* (International Classification of Diseases \[ICD\]-10 C25.0 Malignant neoplasm: Head of pancreas, C25.1: Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas, C25.3 Malignant neoplasm: Pancreatic duct and C25.9 Malignant neoplasm: Pancreas, unspecified). Any ICD-10 code in the C25 section (malignant neoplasm of pancreas) will be acceptable
* Histologically verified, locally advanced (stage II/III) or metastatic (stage IV) adenocarcinoma of the pancreas
* The PDAC must be visible on grayscale ultrasound prior to injection of ultrasound contrast
* Must be ambulatory with an ECOG performance status between 0 and 2
* Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun \> 15 days prior to the screening visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomized partner (6 months minimum). Male patients must also agree to practice throughout the study an approved method of birth control.
\* (Note: To be considered NOT of child-bearing potential, female patients must be postmenopausal \[with amenorrhea for at least 2 year…