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

Trial ID or NCT#

NCT02599194

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Written informed consent* Able to complete a PET/CT scan without the use of sedation* Females:
  2. * Of childbearing potential must:
  3. * 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:
  4. * 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:
  1. * 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
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Investigator(s)

Andrei Iagaru
Andrei Iagaru
Radiologist
Professor of Radiology (Nuclear Medicine)
Melinda L. Telli, M.D.
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov