Clinical trial NCT01931709: FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer
Official title: Quantitative Dynamic PET and MRI and Breast Cancer Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-08-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 criteria: 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

Primary outcomes:
measure: Number of Participants With Favorable Pathologic Response at Surgery
timeFrame: At time of surgery
Secondary outcomes:
measure: Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response
timeFrame: Baseline to up to 12 weeks (mid-therapy)
measure: Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response
timeFrame: Baseline to up to 12 weeks (mid-therapy)
measure: Time From Surgery to Breast Cancer Recurrence
timeFrame: The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status.
measure: Time of Surgery to Overall Survival
timeFrame: Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive.
measure: Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response
timeFrame: Baseline to up to 12 weeks (mid-therapy)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Jennifer Specht
role: PRINCIPAL_INVESTIGATOR
References: