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

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Newly Diagnosed Breast Cancer

Treatments: Diagnostic Test: Hybrid breast FDG PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03510988

1705018188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 25+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Women with newly diagnosed breast cancer

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Hybrid breast FDG PET/MRI