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

University of Washington

Status: Terminated

Conditions: Stage IIIA Breast Cancer; Male Breast Cancer; Stage IIIB Breast Cancer; Stage II Breast Cancer

Treatments: Device: dynamic contrast-enhanced magnetic resonance imaging; Other: laboratory biomarker analysis; Device: positron emission tomography; Radiation: fludeoxyglucose F 18

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01931709

RG1712020 (Other Identifier)

7587 (Other Identifier)

P50CA138293 (U.S. NIH Grant/Contract)

NCI-2013-01668 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Diagnostic (FDG PET and DCE-MRI)

Experimental group

Description:

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).

Treatment:

Other: laboratory biomarker analysis

Radiation: fludeoxyglucose F 18

Device: positron emission tomography

Device: dynamic contrast-enhanced magnetic resonance imaging