18F-FSPG PET/CT for Cancer Patients on Therapy
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.
Checked against the public recordLast updated Jan 3, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Andrei Iagaru
- Interventions being studied
- Drug: 18F-FSPG; Drug: 18F-FDG
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Stanford University Medical CenterStanford, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 3, 2019. Always confirm current availability with the study team.