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PET/CT Evaluation of Treatment Response in Breast Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01222416
First Posted: October 18, 2010
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
  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: None (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 A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) [ Time Frame: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery) ]
    The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the


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 ]

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, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
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, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 29, 2010
First Posted: October 18, 2010
Results First Submitted: March 21, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiopharmaceuticals
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action