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

• Status: Completed
• Trial end date: 2016-12-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluorodeoxyglucose F18

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