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

NCT06008301 | Withdrawn

• 1 other identifier: H-44009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Female

Keywords

Contrast enhanced mammography (CEM); Breast MRI; Financial costs; Time costs; State-trait anxiety inventory (STAI)

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Consent for the entire study

EXPERIMENTAL

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)

Consent only for the STAI

ACTIVE COMPARATOR

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)

Interventions

State-Trait Anxiety Inventory (STAI) OTHER

The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.

Consent for the entire study; Consent only for the STAI

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Breast Cancer Alliance: collaborator

Study Officials

• Jordana Phillips, MD FSBI

  Boston Medical Center, Dept of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share