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

Completed · Phase 2

Conditions studied: B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Metastatic Renal Cell Cancer, Progesterone Receptor Negative, Stage III Mesothelioma, Stage III Renal Cell Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV Mesothelioma, Stage IV Non-Small Cell Lung Cancer, Stage IV Renal Cell Cancer, Triple-Negative Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT02599194

Run by

Andrei Iagaru

People needed

7

Starts

2015-07-01

Expected to finish

2016-12-14

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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