Trial Search Results

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

The goal of this Phase II clinical trial is to further evaluate the ability of 18F-FSPG to diagnose, prognosticate, and evaluate response to therapy in patients with a wide variety of metastatic cancers.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Erik Mittra

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Procedure: Computed Tomography
  • Drug: Fluorine F 18 L-glutamate Derivative BAY94-9392
  • Procedure: Positron Emission Tomography
  • Procedure: Magnetic Resonance Imaging

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting