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

NCT03510988 | Terminated Results FDA Device

• 1 other identifier: 1705018188
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  24 months post-intervention

• Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format.

  24 months post-intervention

• Number of Interval Recurrences

  24 months post-intervention

• 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 post-intervention

• Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized

  24 months post-intervention

Study Arms (1)

Women with newly diagnosed breast cancer

EXPERIMENTAL

Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care.

Diagnostic Test: Hybrid breast FDG PET/MRI

Interventions

Hybrid breast FDG PET/MRI DIAGNOSTIC_TEST

Hybrid breast FDG PET/MRI

Women with newly diagnosed breast cancer

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Limitations and Caveats

Wilson method was not utilized for the confidence intervals for multiple outcome measures at this time.

Results Point of Contact

• Title: Katerina Dodelzon, MD
• Organization: Weill Cornell Medicine

kad9090@med.cornell.edu

646 962 9650

Study Officials

• Katerina Dodelzon, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 27, 2018
• Study Start: March 15, 2018
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2022
• Last Updated: February 22, 2023
• Results First Posted: February 22, 2023

Record last verified: 2023-01

Locations

US (1)