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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2022-10-26

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Male Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (FDG PET and DCE-MRI)

Patients undergo FDG PET and DCE-MRI 1-2 weeks 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).

Group Type EXPERIMENTAL

fludeoxyglucose F 18

Intervention Type RADIATION

Undergo FDG PET

positron emission tomography

Intervention Type DEVICE

Undergo FDG PET

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type DEVICE

Undergo DCE-MRI

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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fludeoxyglucose F 18

Undergo FDG PET

Intervention Type RADIATION

positron emission tomography

Undergo FDG PET

Intervention Type DEVICE

dynamic contrast-enhanced magnetic resonance imaging

Undergo DCE-MRI

Intervention Type DEVICE

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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18FDG FDG FDG-PET PET PET scan tomography, emission computed DCE-MRI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No