This clinical trial determines how well arterial spin labeled (ASL) magnetic resonance imaging (MRI) works in detecting treatment response in patients with kidney cancer that has spread to other places in the body (metastatic). ASL MRI is a way to measure blood flow in the body without using contrast agents, and may be more effective than standard imaging in detecting treatment response in patients with kidney cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04831138.
PRIMARY OBJECTIVE:
I. To determine whether ASL-measured perfusion can identify treatment response (time to progression) earlier than the currently used Response Evaluation Criteria in Solid Tumors (RECIST) in patients undergoing anti-angiogenic treatment.
SECONDARY OBJECTIVES:
I. To determine the correlation between ASL-measured baseline perfusion and the treatment response (progression-free survival [PFS], overall survival [OS]).
II. To determine the correlation between post-treatment changes in ASL-measured perfusion at T1, T2 and T3 compared to baseline and the treatment response (PFS, OS).
III. To predict responders from non-responders (progression versus not at 7 months) with measurements at baseline and at earlier time points (T1 and T2) using:
IIIa. ASL-measured perfusion alone
IIIb. ASL-measured perfusion in combination with other magnetic resonance (MR) imaging metrics such as diffusion weighted imaging (DWI) derived apparent diffusion coefficient (ADC), and chemical exchange saturation transfer (CEST) measured CEST effect.
EXPLORATORY OBJECTIVE:
I. To determine whether ASL-measured perfusion can identify treatment response (time to progression) earlier than the currently used RECIST criteria in patients undergoing immunotherapy (IO).
OUTLINE:
Patients undergo MRI with intravenous (IV) gadolinium-based contrast and ASL without contrast over 1 hour total at baseline, day 7, and day 14 after start of standard of care treatment. Patients then undergo 3 additional MRI and ASL imaging sessions at the time of standard clinical imaging until 7 months.
After completion of study treatment, patients are followed up per standard clinical examinations for the next 3 years.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorAnanth J. Madhuranthakam