Adults with one or more metastatic tumors who have tried or are not eligible for other therapies are invited to be in a research study that uses focused ultrasound ablation therapy (AM003)

IRB/UVA Tracking #
21850
Principal Investigator
Lynn T Dengel
Contact
Adela Mahmutovic
Contact Phone
434.982.6914
Official Trial Title
PILOT EVALUATION OF FOCUSED ULTRASOUND ABLATION AND FOCUSED ULTRASOUND ABLATION PLUS PD-1 ANTIBODY BLOCKADE IN ADVANCED SOLID TUMORS
Study Description

The Department of Surgery seeks adults with advanced solid tumors for a research study. The study is trying to figure out the safety and effectiveness of a treatment called focused ultrasound ablation (FUSA) administered alone or with a PD-1 antibody blockade (a type of infused immune therapy drug) and/or a topical medicine that affects the immune system called imiquimod (Aldara). FUSA is administered using an investigational device called the Echopulse®.

You may be eligible for this study if you have one or more metastatic tumors (tumors that have spread to different parts of the body) that are close to the surface of the skin or in a lymph node. You also must have tried other therapies or not be eligible for other therapies.

The study has different groups depending on if PD-1 antibody blockade therapy is standard treatment for your disease type. The study involves having the focused ultrasound ablation treatment 1-2 times, having your blood drawn, having your tumor biopsied 3-6 times, and participating in a pain assessment survey. These will be done in 5 or 7 visits over 85 days, depending on which group you are in. Each visit will last 2-6 hours.

Study-related treatment and procedures, including focused ultrasound ablation therapy and tumor biopsies, will be provided at no cost. Participant’s insurance company will be billed for standard of care treatment and procedures, including treatment with PD-1 blockade therapy if applicable.

For more information, please visit: https://www.clinicaltrials.gov/ct2/show/NCT04116320

Compensation

None