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

Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: State-Trait Anxiety Inventory (STAI)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Consent for the entire study; 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.	Other: State-Trait Anxiety Inventory (STAI); The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.
Active Comparator: Consent only for the 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.	Other: State-Trait Anxiety Inventory (STAI); The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Institutional financial costs	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.	24 months
Patient financial costs	Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.	24 months
Time from diagnosis to imaging modality (CEM or MRI)	Time will be measured in days and abstracted from medical records.	24 months
Time from diagnosis to first treatment	Time will be measured in days and abstracted from medical records.	24 months
Number of patient visits generated from the imaging modality	Number of patient visits generated from the imaging modality will be abstracted from medical records.	24 months
Psychologic costs to patients	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.	24 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Breast Cancer Alliance
• Investigators: Principal Investigator: Jordana Phillips, MD FSBI, Boston Medical Center, Dept of Radiology

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breast MRI; Contrast enhanced mammography (CEM); Financial costs; Time costs; State-trait anxiety inventory (STAI)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: H-44009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No