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

• ClinicalTrials.gov Identifier: NCT03510988
• Recruitment Status: Terminated
• First Posted: April 27, 2018
• Last Update Posted: January 28, 2022
• Sponsor: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

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	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.

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: March 15, 2018
• Actual Primary Completion Date: March 4, 2020
• Actual Study Completion Date: March 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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

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

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03510988
• Other Study ID Numbers: 1705018188
• First Posted: April 27, 2018
• Last Update Posted: January 28, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases