Breast Cancer Clinical Trial

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

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.

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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.

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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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT02599194

Recruitment Status:

Completed

Sponsor:

Andrei Iagaru

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There is 1 Location for this study

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Stanford University Medical Center
Stanford California, 94304, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT02599194

Recruitment Status:

Completed

Sponsor:


Andrei Iagaru

How clear is this clinincal trial information?

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