Trial record 1 of 1 for:    In Vivo Cell Proliferation Marker by PET
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PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01712815
First received: October 18, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • 18F-2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine
  • 18F-FMAU
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712815

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Andrea Contreras    323-226-7623    a.contreras@usc.edu   
Contact: Bhushan Desai    323-652.0343    bhushand@usc.edu   
Principal Investigator: Peter S. Conti         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Peter Conti University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
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: March 4, 2014
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 July 24, 2014