18F-FSPG PET/CT for Cancer Patients on Therapy
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/5/2019 |
| Start Date: | July 2015 |
| End Date: | December 14, 2016 |
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving 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.
used before and after treatment to diagnose, predict, and evaluate response to therapy in
patients with a wide variety of metastatic cancers.
OUTLINE:
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG
[18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before
and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and
compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group
of patients.
SECONDARY OBJECTIVES:
- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and
18F-FDG.
- Safety and tolerability of 18F-FSPG and 18F-FDG.
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG
[18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before
and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and
compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group
of patients.
SECONDARY OBJECTIVES:
- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and
18F-FDG.
- Safety and tolerability of 18F-FSPG and 18F-FDG.
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
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