18F-FSPG PET/CT for Cancer Patients on Therapy
Trial ID or NCT#
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
- - Written informed consent - Able to complete a PET/CT scan without the use of sedation - Females: - Of childbearing potential must: - Not be nursing - Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT - Not of childbearing potential must be: - Physiologically postmenopausal (cessation of menses for more than 1 year) - Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy) - Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent - Scheduled to begin therapy - The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options) - Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion) - No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
- - Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration - Known sensitivity to 18F FSPG or components of the preparation - Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
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