PET/CT Evaluation of Treatment Response in Breast Cancer

This study has been terminated.
(Study objectives were met)
Sponsor:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01222416
First received: September 29, 2010
Last updated: August 24, 2015
Last verified: August 2015
  Purpose
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.

Condition Intervention
Breast Cancer
Radiation: Radiopharmaceutical Administration [18F]-FDG
Radiation: Radiopharmaceutical: [18F]-FLT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Changes in the standard uptake value (SUV) and Gadolinium contrast parameters will be used as a predictor of response then correlated to complete pathologic response measured at the time of definitive surgery. [ Time Frame: Prior to chemotherapy, within 7-14 days following the start of chemotherapy and immediately prior to surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare and combine magnetic resonance imaging (MRIs) (obtained from study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) methods to develop a robust assessment of tumor status. [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluorodeoxyglucose PET/CT (FDG-PET/CT)
A PET/CT scan prior to the initiation of therapy, after the first cycle of therapy, and just prior to initiation of the second cycle of therapy (i.e., up to three scans/patient).
Radiation: Radiopharmaceutical Administration [18F]-FDG
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Experimental: fluorodeoxythymidine PET/CT (FLT-PET/CT)
A PET/CT scan prior to the initiation of therapy, after the first cycle of therapy, and just prior to initiation of the second cycle of therapy (i.e., up to three scans/patient).
Radiation: Radiopharmaceutical: [18F]-FLT
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subjects must have histologically proven breast cancer
  • Subjects are being considered for preoperative chemotherapy
  • Subjects must be ≥ 18 years old. Sensor Sub-Study Only
  • Palpable subcutaneous or known disease with one surface <1cm below surface of skin.
  • A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.

Exclusion Criteria

  • Children will be excluded from this study.
  • Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
  • Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
  • Intraluminal lesions will be excluded from the sensor sub-study.
  • Non biopsy proven malignancy will be excluded from this study.
  • Palpable subcutaneous or known disease with one surface >1cm below surface of skin will be excluded from the sensor sub-study.
  • Draining or exposed malignant tumor will be excluded from the sensor sub-study.
  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: NCT01222416

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01222416     History of Changes
Other Study ID Numbers: VICC BRE 09108 
Study First Received: September 29, 2010
Last Updated: August 24, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016