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

Newly Diagnosed Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03510988
• Other study ID #: 1705018188
• Status: Terminated
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: March 4, 2022

Study information

• Verified date: January 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Newly Diagnosed Breast Cancer

Intervention

Diagnostic Test:
• Hybrid breast FDG PET/MRI
Hybrid breast FDG PET/MRI

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer	Blinded breast imaging readers were provided at random a reading list of anonymized studies of breast PET/MRIs and MRI alone from the study cohort and asked to assess lesions suspicious for malignancy. Specificity of all lesions on PET-MRI compared to MRI alone is assessed by the percentage of true negatives out of all benign/non-malignant lesions.	24 months
Secondary	Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) 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.	Blinded radiologists evaluated a list of anonymized studies of breast MRI alone and after washout period the same MRI with ovelayed PET from a hybrid PETMRI study cohort and asked to assess lesions suspicious for malignancy in addition to known index tumor. Measures of diagnostic accuracy( sensitivity, specificity, PPV and NPV) for any and all additional lesions exclusive of the known index tumor detected by readers were calculated for MRI alone and for PET/MRI. Due to washout period readers assessed the imaging of hybrid PET/MRI in complement, as such readers may assess previously questioned MRI findings as benign in the absence of FDG uptake. Sensitivity is the % of true positive & specificity is the % of true negative. PPV is the probability that if imaging was assessed as suspicious on biopsy was malignant. NPV is the % likelihood that if imaging was assessed as negative there was no additional malignancy on surgical excision.	24 months post-intervention
Secondary	Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format.	PET imaging was assessed for signal-to-noise ratio of maximum standardized uptake value (SUVmax) over the breast background SUVmean. This is compiled below for each administered dose of FDG. Each subject received one FDG and one gadolinium dose IV injection.	24 months post-intervention
Secondary	Number of Interval Recurrences		24 months post-intervention
Secondary	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	Blinded breast imaging readers were provided at random a reading list of anonymized studies of breast PET/MRIs and MRI alone from the study cohort and asked to assess nodal disease as a whole (present/absent). Sensitivity, specificity, PPV (positive predictive value), and NPV (negative predictive value) of nodal metastasis (presence or absence) of hybrid breast FDG PET/MRI vs breast MRI alone were compared. Due to washout period readers assessed the imaging of hybrid PET/MRI in complement, as such readers may assess previously questioned MRI findings as benign in the absence of FDG uptake.	24 months post-intervention
Secondary	Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized	Subjects will be asked to fill out a questionnaire at the conclusion of their breast PET/MRI exam assessing on a scale of 1 - 5 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.	24 months post-intervention