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Clinical Trial · NCT02599194
18F-FSPG PET/CT for Cancer Patients on Therapy
Overview
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.
Sponsor
Stanford University
Phase
Phase 2
Contacts
Andrei M Iagaru, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT02599194Drug / Compound
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
FSPG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Cystine/glutamate antiporter
Ligand Class: Small Molecules
Eligibility
Inclusion
- 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
- Able to complete a PET/CT scan without the use of sedation
- 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)
- Not of childbearing potential must be:
- Females:
- Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
- Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
- Physiologically postmenopausal (cessation of menses for more than 1 year)
- Not be nursing
- Of childbearing potential must:
- Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT
- 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)
- Scheduled to begin therapy
Exclusion
- 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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