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1B-11-9 Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer

Description

Advances in imaging techniques, particularly MRI and CT, have improved the detection and staging of tumors, as well as assessment of therapeutic response in cancer patients. Recent advances suggest that it may be possible to evaluate cell division, one of the most basic processes of tumors, using positron emission tomography (PET). The main objectives of this study are to study [18F]FMAU in 10 patients with known breast cancer to obtain data on safety, circulating metabolite, tumor imaging feasibility, and radiation dosimetry. This will help us to evaluate the potential use of FMAU-PET as an imaging agent for chemotherapeutic response in 15 patients with breast cancer.Patients enrolled for this study will have laboratory confirmed breast cancer. Once participants sign the informed consent and are confirmed to be eligible, they will begin the study. Participants in part 1 will have a one-time [18F] FMAU PET scan before beginning treatment for their cancer. Participants in part 2 will have 3 study visits: before they start cancer therapy, 1 week before their second cycle of chemotherapy, and after completing chemotherapy. The following procedures will be performed during each visit: a physical exam, vital signs, pregnancy test, review of medical history, electrocardiogram (EKG) to assess heart function, and a partial body [18F] FMAU PET scan. All study participants will be followed 24 hours after each PET scan to monitor for any potential side effects.In part 1, a physician will interpret the PET scan to establish baseline values. Part 2 will test the correlation of the PET score at baseline versus PET scores at the later time points outlined above. We will also test the correlation of tumor appearance (i.e. histology) from surgical specimens versus baseline in conjunction with the change of PET score. Statistical analysis will be performed to evaluate tumor response.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion criteria for Aim 1:
  • Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard care
  • Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU Inclusion criteria for Aim 2:
  • Have been diagnosed with a HER2+ invasive cancer of the breast
  • Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care
  • Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU

  • Have undergone chemotherapy or radiation therapy within the previous one month
  • Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure
  • Patients who have had surgery at the site of the suspected lesion within 1 month

Sites

  • California

    • USC Norris Comprehensive Cancer Center, Los Angeles, California, 90033
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