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NCT01712815 Clinical Trial

PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

HER2-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01712815
Other study ID # 1B-11-9
Secondary ID NCI-2012-02041
Status Terminated
Phase N/A
First received
Last updated
Start date November 22, 2013
Est. completion date November 1, 2022

Study information
Verified date August 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis
Correlative studies
• pharmacological study
Correlative studies
• questionnaire administration
Ancillary studies
Radiation:
• fluorine F 18-clevudine
Undergo fluorine F 18-clevudine PET/CT scan
Procedure:
• positron emission tomography/computed tomography
Undergo fluorine F18-clevudine PET/CT scan

Locations
Country Name City State
United States USC Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy Up to 1 year
Primary Incidence of adverse events Up to 24 hours after completion of study treatment
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