Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-22 @ 11:40 AM
Study NCT ID:
NCT02599194
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2015-11-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18F-FSPG PET/CT for Cancer Patients on Therapy
Sponsor:
Andrei Iagaru
Organization:
Study Overview
Official Title:
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-01125 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| VARIMG0006 | OTHER | OnCore ID | View | |
| P30CA124435 | NIH | None | https://reporter.nih.gov/quic… | View |