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18F-FSPG PET/CT for Cancer Patients on Therapy
Not Recruiting
Trial ID: NCT02599194
Purpose
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.
Official Title
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
Stanford Investigator(s)
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Melinda L. Telli, M.D.
Professor of Medicine (Oncology)
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Intervention(s):
drug: 18F-FSPG
drug: 18F-FDG
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061