PET/CT Evaluation of Treatment Response in Breast Cancer

NCT01222416 | Terminated Results DMC

• 1 other identifier: VICC BRE 09108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)

  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

  up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)

Secondary Outcomes (1)

• 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.

  48 months

Study Arms (2)

fluorodeoxyglucose PET/CT (FDG-PET/CT)

EXPERIMENTAL

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

fluorodeoxythymidine PET/CT (FLT-PET/CT)

EXPERIMENTAL

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

Interventions

Radiopharmaceutical Administration [18F]-FDG RADIATION

Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.

fluorodeoxyglucose PET/CT (FDG-PET/CT)

Radiopharmaceutical: [18F]-FLT RADIATION

Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.

fluorodeoxythymidine PET/CT (FLT-PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorodeoxyglucose F18; Radiopharmaceuticals; alovudine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Results Point of Contact

• Title: A Bapsi Chakravarthy, MD Program Director, Radiation Oncology
• Organization: Vanderbilt-Ingram Cancer Center

babsi.chak@vanderbilt.edu

615-322-2555

Study Officials

• A. Bapsi Chakravarthy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Radiation Oncologist

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)