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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06008301
Enrollment
0
Registered
2023-08-23
Start date
2025-04-30
Completion date
2027-06-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Keywords

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

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.

Interventions

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

Sponsors

Breast Cancer Alliance
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Institutional financial costs24 monthsTrue 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.
Patient financial costs24 monthsPatient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
Time from diagnosis to imaging modality (CEM or MRI)24 monthsTime will be measured in days and abstracted from medical records.
Time from diagnosis to first treatment24 monthsTime will be measured in days and abstracted from medical records.
Number of patient visits generated from the imaging modality24 monthsNumber of patient visits generated from the imaging modality will be abstracted from medical records.
Psychologic costs to patients24 monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026