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

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ClinicalTrials.gov Identifier: NCT01931709
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 26, 2013
August 29, 2013
March 24, 2017
June 14, 2017
June 14, 2017
November 2011
February 2016   (Final data collection date for primary outcome measure)
Number of Participants With Favorable Pathologic Response at Surgery [ Time Frame: At time of 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:

  1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0)
  2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)
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 ]
The primary clinical endpoint is dichotomous (yes/no). Associations with pathologic response will be estimated using logistic regression.
Complete list of historical versions of study NCT01931709 on ClinicalTrials.gov Archive Site
  • Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ]
    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.
  • Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ]
    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.
  • Time From Surgery to Breast Cancer Recurrence or Death [ Time Frame: From surgery to breast cancer recurrence or death, assessed up to 5 years ]
    Will be examined using Cox proportional hazards regression.
  • Overall Survival [ Time Frame: From time of surgery until death, assessed up to 5 years ]
    Will be examined using Cox proportional hazards regression.
  • 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 [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ]
    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.
  • Percent change in tumor perfusion [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ]
    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) ]
    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 ]
    Will be examined using Cox proportional hazards regression.
  • Overall Survival [ Time Frame: From time of surgery until death, assessed up to 5 years ]
    Will be examined using Cox proportional hazards regression.
Not Provided
Not Provided
 
FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer
Quantitative Dynamic PET and MRI and Breast Cancer Therapy
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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Male Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • 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
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).
Interventions:
  • Radiation: fludeoxyglucose F 18
  • Device: positron emission tomography
  • Device: dynamic contrast-enhanced magnetic resonance imaging
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
Not Provided
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01931709
7587
NCI-2013-01668 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7587 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
P50CA138293 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Jennifer Specht, University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Jennifer Specht Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP