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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT03510988

Collaborator

(none)

Enrollment

Location

Arm

23.7

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 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 :

Mar 15, 2018

Actual Primary Completion Date :

Mar 4, 2020

Actual Study Completion Date :

Mar 4, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Women with newly diagnosed breast cancer

Diagnostic Test: Hybrid breast FDG PET/MRI

Hybrid breast FDG PET/MRI

Outcome Measures

Primary Outcome Measures

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 [24 months]

Secondary Outcome Measures

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. [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.
Average signal to noise ratios (SNR) vs. IV FDG dosages will be summarized in plot format. [24 months]
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 [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.
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 [24 months]
Perceived patient benefit of undergoing a simultaneous FDG PET/MRI will be summarized [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Katerina Dodelzon, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT03510988

Other Study ID Numbers:

1705018188

First Posted:

Apr 27, 2018

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jan 28, 2022