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Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer

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.
 
ClinicalTrials.gov Identifier: NCT03510988
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : April 27, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This is a single institution study enrolling women over age 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care. Subjects will undergo a hybrid dedicated Breast PET/MRI in lieu of a breast MRI alone, for evaluation of extent of disease prior to surgical and oncologic management. The study will investigate any incremental added benefit to breast MRI specificity by the addition of concurrent hybrid breast PET.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Breast Cancer Diagnostic Test: Hybrid breast FDG PET/MRI Not Applicable

Detailed Description:
The study hypothesis is that the combination of Breast PET/MRI, will improve specificity and decrease the number of false positive breast biopsies recommended based on breast MRI findings.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Women with newly diagnosed breast cancer Diagnostic Test: Hybrid breast FDG PET/MRI
Hybrid breast FDG PET/MRI




Primary Outcome Measures :
  1. Evaluate the specificity by adding breast FDG PET to MRI compared with breast MRI alone for the diagnosis on patients with newly diagnosed breast cancer [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Sensitivity, PPV, and NPV for the diagnosis based on the entire PET/MRI and MRI alone will be calculated and reported along with the corresponding two-sided 90% confidence intervals constructed by Wilson score method. [ Time Frame: 24 months ]
    Sensitivity, PPV, and NPV for the diagnosis based on the entire PET/MRI and MRI alone will be calculated and reported along with the corresponding two-sided 90% confidence intervals constructed by Wilson score method. Subsequent paired McNemar's tests will be used to compare each diagnosis metric based on the two imaging modalities.

  2. Average signal to noise ratios (SNR) vs. IV FDG dosages will be summarized in plot format. [ Time Frame: 24 months ]
  3. Logistic regression and a cox proportional hazard model will be generated between hybrid FDG PET/MRI imaging features and tumor biology and tumor recurrence, respectively [ Time Frame: 24 months ]
    Logistic regression and a cox proportional hazard model will be generated between hybrid FDG PET/MRI imaging features (SUV, T2 characteristics, enhancement pattern, kinetic curve, DWI) and tumor biology (pathological type, receptor status, Ki-67 and oncotype) and tumor recurrence (using a surrogate of Ki-67 and oncotyping when available), respectively.

  4. Sensitivity in detection of axillary and internal mammary lymph node metastasis between the hybrid breast FDG PET/MRI vs breast MRI alone will be summarized [ Time Frame: 24 months ]
  5. Perceived patient benefit of undergoing a simultaneous FDG PET/MRI will be summarized [ Time Frame: 24 months ]
    Subjects will be asked to fill out a questionnaire at the conclusion of their breast PET/MRI exam assessing on a scale of 1 - 7 how important it was for them to save time to do the PET/MRI simultaneously knowing that they may have a negative PET/MRI for extent of disease (no additional sites of disease aside from index cancer), how valuable it is for them to potentially avoid unnecessary biopsies if the study hypothesis is correct, and how important it is to them to decrease delay to surgery.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women over age of 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care

Exclusion Criteria:

  • Male subjects
  • Women younger than 25
  • Pregnant subjects
  • Unable or unwilling to undergo MRI
  • Previous adverse reaction to 18F-FDG
  • Unwilling to undergo biopsy of MRI positive lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510988


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Katerina Dodelzon, MD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03510988    
Other Study ID Numbers: 1705018188
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases