Hyperpolarized 13C Pyruvate Metabolic MRI to Predict Renal Tumor Aggressiveness

Who is this study for? Patients with renal tumors
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This feasibility study will evaluate how well hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) scan works in predicting tumor aggressiveness in participants with renal tumors. Hyperpolarized 13C pyruvate is a non-radioactive substance with potential usage in the diagnostic imaging of tumors. Hyperpolarized 13C pyruvate MRI may help doctors determine non-invasively whether a kidney tumor is a benign tumor or cancer, and if cancer, how aggressive it is. This may help doctors and participants with renal tumors in the future to make better treatment decisions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, the investigators have limited the lower size range of the tumor to 1 cm. The investigators will include all renal tumor measuring 1 cm and greater in diameter in this first study to facilitate obtaining tumors of a range of histology and grade.

• The participant is being considered by the treating physician to have any of the following management options: partial or radical nephrectomy, ablation, or active surveillance for his/her renal tumor.

• The participant is able and willing to comply with study procedures and provide signed and dated informed consent.

• The participant is willing to undergo standard of care abdominal MRI in connection with the study exam.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Zhen Jane Wang, MD
Zhen.Wang@ucsf.edu
415-476-3767
Backup
Maya Aslam
Maya.Aslam@ucsf.edu
Time Frame
Start Date: 2019-01-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Diagnostic (HP 13C pyruvate with MRI)
Participants receive HP 13C pyruvate IV and then undergo 13C MRI scan 1-2 minutes post HP 13C pyruvate injection. Participants may receive an optional second HP 13C pyruvate injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI
Experimental: Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)
Participants receive HP 13C pyruvate and 13C 15N2 urea IV and then undergo an MRI scan 1-2 minutes post injection. Participants may receive an optional second HP 13C pyruvate with 13C 15N2 urea injection and undergo a second MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI
Related Therapeutic Areas
Sponsors
Leads: Zhen Wang, MD
Collaborators: American Cancer Society, Inc., National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov