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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008301
• Other study ID #: H-44009
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: Boston Medical Center
• Contact: Jordana Phillips, MD FSBI
• Phone: (617) 638-6632
• Email: jordana.phillips[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Breast Cancer Alliance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient financial costs	Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.	24 months
Primary	Time from diagnosis to imaging modality (CEM or MRI)	Time will be measured in days and abstracted from medical records.	24 months
Primary	Time from diagnosis to first treatment	Time will be measured in days and abstracted from medical records.	24 months
Primary	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
Primary	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