Parametric PET of Genitourinary Cancer (NCT04020978) | Clinical Trial Compass
CompletedNot Applicable
Parametric PET of Genitourinary Cancer
United States11 participantsStarted 2019-07-16
Plain-language 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 few cycles (months) of treatment to evaluate response. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies. The goal of this study is to evaluate a parametric PET method that potentially identify response and assess drug efficacy with a few days to weeks of treatment.
Who can participate
Age range21 Years – 100 Years
SexALL
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Inclusion Criteria:
* 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: …