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

Stage IIIA Breast Cancer Clinical Trial

Official title:

Quantitative Dynamic PET and MRI and Breast Cancer Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01931709
• Other study ID #: 7587
• Secondary ID: NCI-2013-0166875
• Status: Terminated
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 26, 2022

Study information

• Verified date: October 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: October 26, 2022
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer

Intervention

Radiation:
• fludeoxyglucose F 18
Undergo FDG PET

Device:
• positron emission tomography
Undergo FDG PET
• dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Favorable Pathologic Response at Surgery	The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as: No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0); Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)	At time of surgery
Secondary	Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response	Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.	Baseline to up to 12 weeks (mid-therapy)
Secondary	Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response	Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.	Baseline to up to 12 weeks (mid-therapy)
Secondary	Time From Surgery to Breast Cancer Recurrence	Mean (range)	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.
Secondary	Time of Surgery to Overall Survival	Mean (range)	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.
Secondary	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	Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.	Baseline to up to 12 weeks (mid-therapy)