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FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

Quantitative Dynamic PET and MRI and Breast Cancer Therapy

NCT01931709•University of Washington

Summary

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment 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.

Detailed Description

PRIMARY OBJECTIVES: I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy. II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue. OUTLINE: Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
•Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven)
•No obvious contraindications for primary chemotherapy
•Able to lie still for PET and MRI scanning
•Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria

•Serious systemic illness other than breast cancer
•Contraindication to MRI or history of adverse reaction to gadolinium
•Evidence of distant disease outside of regional lymph nodes
•Pregnant
•Poorly controlled diabetes mellitus (fasting blood glucose \> 200)
•Prior systemic cancer therapy

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

February 1, 2016

Completion Date

October 26, 2022

Last Updated

November 18, 2023

Enrollment

ACTUAL participants

Conditions

Male Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast Cancer

Interventions

fludeoxyglucose F 18

RADIATION

positron emission tomography

DEVICE

dynamic contrast-enhanced magnetic resonance imaging

DEVICE

laboratory biomarker analysis

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

Inclusion Criteria

Exclusion Criteria

Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial

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