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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:
ClinicalTrials.gov Identifier:
NCT01931709
First Posted: August 29, 2013
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jennifer Specht, University of Washington
Results First Submitted: March 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Interventions: Radiation: fludeoxyglucose F 18
Device: positron emission tomography
Device: dynamic contrast-enhanced magnetic resonance imaging
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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).

fludeoxyglucose F 18: Undergo FDG PET

positron emission tomography: Undergo FDG PET

dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Diagnostic (FDG PET and DCE-MRI)
STARTED   35 
COMPLETED   35 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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).

fludeoxyglucose F 18: Undergo FDG PET

positron emission tomography: Undergo FDG PET

dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Diagnostic (FDG PET and DCE-MRI) 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Median (Full Range)
 43 
 (31 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      35 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   5.7% 
Not Hispanic or Latino      33  94.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   5.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      33  94.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Clinical stage 
[Units: Participants]
Count of Participants
 
IIA      9  25.7% 
IIB      8  22.9% 
IIIA      9  25.7% 
IIIB      3   8.6% 
IIIC      6  17.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Favorable Pathologic Response at Surgery   [ Time Frame: At time of surgery ]

2.  Secondary:   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) ]

3.  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   [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ]

4.  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   [ Time Frame: Baseline to up to 12 weeks (mid-therapy) ]

5.  Secondary:   Time From Surgery to Breast Cancer Recurrence or Death   [ Time Frame: From surgery to breast cancer recurrence or death, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Overall Survival   [ Time Frame: From time of surgery until death, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jennifer Specht, MD
Organization: University of Washington
phone: 206-288-6889
e-mail: jspecht@uw.edu



Responsible Party: Jennifer Specht, University of Washington
ClinicalTrials.gov Identifier: NCT01931709     History of Changes
Other Study ID Numbers: 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 )
First Submitted: August 26, 2013
First Posted: August 29, 2013
Results First Submitted: March 24, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017