18F-FSPG PET/CT for Cancer Patients on Therapy

Andrei Iagaru

Status and phase

Completed

Phase 2

Conditions

Stage IIIA Breast Cancer

Metastatic Renal Cell Cancer

HER2/Neu Negative

Triple-Negative Breast Carcinoma

Stage IV Renal Cell Cancer

Stage IV Mesothelioma

Stage IIIB Non-Small Cell Lung Cancer

Stage III Mesothelioma

B-Cell Neoplasm

Stage IV Non-Small Cell Lung Cancer

Estrogen Receptor Negative

Stage IIIC Breast Cancer

Progesterone Receptor Negative

Stage IIIA Non-Small Cell Lung Cancer

Stage III Renal Cell Cancer

Stage IV Breast Cancer

Treatments

Drug: 18F-FDG

Drug: 18F-FSPG

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02599194

VARIMG0006 (Other Identifier)

NCI-2015-01125 (Registry Identifier)

P30CA124435 (U.S. NIH Grant/Contract)

IRB-31855

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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