Brief Title
18F-FSPG PET/CT for Cancer Patients on Therapy
Official Title
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Secondary Outcome
Number of Treatment-Related Adverse Events
Condition
B-Cell Neoplasm
Intervention
18F-FSPG
Study Arms / Comparison Groups
18F-FSPG and 18F-FDG Intragroup Comparision
Description: Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
7
Start Date
July 2015
Completion Date
December 14, 2016
Primary Completion Date
December 14, 2016
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrei M Iagaru, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02599194
Organization ID
IRB-31855
Secondary IDs
NCI-2015-01125
Responsible Party
Sponsor-Investigator
Study Sponsor
Andrei Iagaru
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Andrei M Iagaru, MD, Principal Investigator, Stanford University
Verification Date
December 2018