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

Not Recruiting

Trial ID: NCT02599194

Purpose

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.

Official Title

An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy

Stanford Investigator(s)

Andrei Iagaru
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Melinda L. Telli, M.D.
Melinda L. Telli, M.D.

Professor of Medicine (Oncology)

Eligibility


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

Intervention(s):

drug: 18F-FSPG

drug: 18F-FDG

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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