- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01222416
PET/CT Evaluation of Treatment Response in Breast Cancer
June 26, 2017 updated by: A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV.
Time interval between administration and scanning: 60 +/- 10minutes post-injection.
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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.
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Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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48 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
September 29, 2010
First Submitted That Met QC Criteria
October 14, 2010
First Posted (Estimate)
October 18, 2010
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC BRE 09108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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