Phase 2
N=7
18F-FSPG PET/CT for Cancer Patients on Therapy
B-Cell Neoplasm · Estrogen Receptor Negative · HER2/Neu Negative · Metastatic Renal Cell Cancer · Progesterone Receptor Negative
Bottom Line
View on ClinicalTrials.gov: NCT02599194 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment — -1.69; -0.64 g/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 18F-FSPG (Drug); 18F-FDG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrei Iagaru
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment |
-1.69; -0.64 | — |
| SECONDARY Number of Treatment-Related Adverse Events |
0; 0 | — |
| SECONDARY Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs |
NA; 11.3; NA; -2.0; NA; -1.3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02599194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.