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Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer


N/A
18 Years
N/A
Not Enrolling
Female
HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

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Trial Information

Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer


PRIMARY OBJECTIVES: I. Study fludeoxyglucose [18F]
2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine (FMAU) (fluorine F 18-clevudine
) in 10 patients with known breast cancer to obtain data on safety, circulating metabolite,
tumor imaging feasibility, and radiation dosimetry. II. Assess the potential utility of
FMAU-PET in the imaging evaluation of chemotherapeutic response in 15 patients with breast
cancer. OUTLINE: Patients receive fluorine F18-clevudine intravenously (IV) over 1
minute and then undergo PET/CT scan at baseline. Patients with human epidermal growth factor
receptor 2 positive (HER2+) breast cancer also undergo fluorine F 18-clevudine PET/CT scan
2-3 weeks after the first course of treatment and after completion of treatment. After
completion of study treatment, patients are followed up at 24 hours.


Inclusion 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Peter Conti

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

1B-11-9

NCT ID:

NCT01712815

Start Date:

October 2012

Completion Date:

October 2015

Related Keywords:

  • HER2-positive Breast Cancer
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms

Name

Location
USC Norris Comprehensive Cancer Center Los Angeles, California  90089