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

NCT ID: NCT06008301

Condition: Breast Cancer Female

Conditions: Official terms:
Breast Neoplasms

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

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: State-Trait Anxiety Inventory (STAI)
Description: The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.
Arm group label: Consent for the entire study
Arm group label: Consent only for the STAI

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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 30 Years

Maximum age: N/A

Healthy volunteers: No

Start date: December 2024

Completion date: December 2026

Lead sponsor:
Agency: Boston Medical Center
Agency class: Other

Collaborator:
Agency: Breast Cancer Alliance
Agency class: Other

Source: Boston Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06008301

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