PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This phase I trial studies the side effects of positron emission tomography (PET)/computed tomography (CT) in evaluating response to chemotherapy in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
| Condition | Intervention |
|---|---|
|
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 |
Other: laboratory biomarker analysis Other: pharmacological study Other: questionnaire administration Radiation: fluorine F 18-clevudine Procedure: positron emission tomography/computed tomography |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer |
- Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: Up to 24 hours after completion of study treatment ] [ Designated as safety issue: Yes ]
- Incidence of Adverse Events [ Time Frame: Up to 24 hours after completion of study treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diagnostic (fluorine F 18-clevudine PET/CT)
Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with 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.
|
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: questionnaire administration
Ancillary studies
Radiation: fluorine F 18-clevudine
Undergo fluorine F 18-clevudine PET/CT scan
Other Names:
Procedure: positron emission tomography/computed tomography
Undergo fluorine F18-clevudine PET/CT scan
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| USC Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: | Peter Conti | USC/Norris Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01712815 History of Changes |
| Other Study ID Numbers: | 1B-11-9, NCI-2012-02041 |
| Study First Received: | October 18, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fluorides 2'-fluoro-5-methylarabinosyluracil |
Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013