Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)

Not Applicable

Withdrawn

• Conditions: Breast Cancer Female
• Interventions: Other: State-Trait Anxiety Inventory (STAI)

• Registration Number: NCT06008301
• Lead Sponsor: Boston Medical Center

Brief Summary

The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.

Specific research objectives are to:

* determine financial costs of performing a CEM to breast MRI

* compare time costs involved with CEM to breast MRI

* compare psychologic costs involved with CEM to breast MRI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-23
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age > or equal to 30 years
• Clinically eligible for CEM or breast MRI
• Newly diagnosed cancer

Exclusion Criteria

• Pregnant as verified by patient report. Given that this test is being performed for clinical purposes, the determination of pregnancy status will be resolved via the standard clinical pathway.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Consent for the entire study	State-Trait Anxiety Inventory (STAI)	Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging.
Consent only for the STAI	State-Trait Anxiety Inventory (STAI)	Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging.

Primary Outcome Measures

Name	Time	Method
Patient financial costs	24 months	Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
Institutional financial costs	24 months	True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.
Time from diagnosis to first treatment	24 months	Time will be measured in days and abstracted from medical records.
Time from diagnosis to imaging modality (CEM or MRI)	24 months	Time will be measured in days and abstracted from medical records.
Number of patient visits generated from the imaging modality	24 months	Number of patient visits generated from the imaging modality will be abstracted from medical records.
Psychologic costs to patients	24 months	The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.