Status:
COMPLETED
Parametric PET of Genitourinary Cancer
Lead Sponsor:
University of California, Davis
Conditions:
Genitourinary Cancer
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
Metastatic kidney cancer is usually treated with targeted therapy or immunotherapy which is costly and has low response rate. The current standard care is to perform anatomical imaging studies after a...
Detailed Description
Renal cell carcinoma (RCC) is one of the top ten cancer types in the US. One-third of RCCs are metastatic and associated with a poor 5-year survival rate of 8%. Metastatic RCC is usually treated with ...
Eligibility Criteria
Inclusion
- Patients with pathologically confirmed GUC. For those patients whose primary kidney cancer is removed, they must have index metastatic cancer lesion(s) within the PET field of view for 18F-FDG parametric PET/CT analysis to determine response.
- Patients are scheduled for targeted cancer therapy, including sunitinib, pazopanib, cabozantinib, everolimus, and others.
- Ability to understand and willingness to sign an informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Men and women ≥21 years of age.
- Life expectancy ≥ 6months.
- Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Or, female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first drug administration.
- Male and female subjects who agree to use highly effective method of birth control (e.g., implants, injectables, birth control pills with two hormones, intrauterine devices \[IUDs\], complete abstinence or sterilized partner, and female sterilization) and a barrier method (e.g., condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of drug.
- For the minority cohort, subject must be a member of a Federally recognized racial/ethnic minority population to include: African Americans or Black; Native American; Alaska Native; Native Hawaiian or other Pacific Islander; Asian American; Hispanic or Latino. This will be verified through self-reporting by the subject.
Exclusion
- Pregnant or lactating women.
- Any condition that would prohibit the understanding or rendering of informed consent.
- Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures.
- Prior treatment with any investigational drug within the previous 4 weeks
- Unable to lie supine for 1-hour imaging with PET
- Prisoners
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04020978
Start Date
July 16 2019
End Date
December 15 2023
Last Update
January 20 2025
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817