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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01931709
First received: August 26, 2013
Last updated: June 23, 2016
Last verified: June 2016
History of Changes
  Purpose
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.

Condition Intervention
Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
 Radiation: fludeoxyglucose F 18
Device: positron emission tomography
Device: dynamic contrast-enhanced magnetic resonance imaging
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantitative Dynamic PET and MRI and Breast Cancer Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Microscopic pathologic response, defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen, as opposed to results "other than pathologic complete response (pCR)" [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    The primary clinical endpoint is dichotomous (yes/no). Associations with pathologic response will be estimated using logistic regression.


Secondary Outcome Measures:
  • Percent change in tumor perfusion [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ] [ Designated as safety issue: No ]
    Relationships between imaging variables and gene expression measured at pre-therapy will be examined by linear regression models.

  • Percent change in tumor metabolism [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ] [ Designated as safety issue: No ]
    Relationships between imaging variables and gene expression measured at pre-therapy will be examined by linear regression models.

  • Time from surgery to breast cancer recurrence or death [ Time Frame: From surgery to breast cancer recurrence or death, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be examined using Cox proportional hazards regression.

  • Overall survival [ Time Frame: From time of surgery until death, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be examined using Cox proportional hazards regression.
Estimated Enrollment: 65
Study Start Date: November 2011
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
 Radiation: fludeoxyglucose F 18
Undergo FDG PET
Other Names:
  • 18FDG
  • FDG
Device: positron emission tomography
Undergo FDG PET
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Device: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Other Name: DCE-MRI
Other: laboratory biomarker analysis
Correlative studies

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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931709

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jennifer Specht Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01931709     History of Changes
Other Study ID Numbers: 7587  NCI-2013-01668  7587  P30CA015704  P50CA138293 
Study First Received: August 26, 2013
Last Updated: June 23, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016