This phase I trial evaluates how well magnetic resonance (MR) guided high intensity focused ultrasound (HIFU) works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). HIFU is a non-invasive treatment used to treat many different tumors. HIFU uses an ultrasound transducer to generate heat using sound waves at a focused location in the body. This allows the study doctor to localize the tumor tissue and destroy it by repeating the process as many times as necessary. MRI images are used to help plan the location of the treatment before and during the procedure. MR guided HIFU may help to reduce pain.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04298242.
PRIMARY OBJECTIVES:
I. Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage.
II. Safety of ablation, as measured by the total frequency and severity of adverse events.
SECONDARY OBJECTIVES:
I. Reduction in pain level, as measured by either:
Ia. A decline in pain score after one week of at least 2 points, or a pain score < 4 out of 10, as assessed by the Brief Pain Inventory.
Ib. A decline after one week in morphine equivalent daily dose (MEDD) of 25%.
II. Evidence of ablation-induced inflammation, defined as post-ablation increases in histologic and/or blood measures of inflammation markers, as measured by either:
IIa. An increase in tumor infiltrating CD8+ T cells.
IIb. A decrease in immune suppressive cells (regulatory T cells [Tregs], macrophages) in the tumor.
IIc. An increase in immune activation signatures (including interferon gamma) in the tumor as measured by ribonucleic acid sequencing (RNAseq).
IId. A change in immune profile in the circulating immune cells (PBMCs) to reflect an activated immune response (e.g. activated T or B cells, reduction in immune suppressive cells or cytokines).
OUTLINE:
Patients undergo MR guided HIFU over 6 hours.
After completion of study treatment, patients are followed up every 30 days for 2 years.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorPejman Ghanouni
