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

NCT ID: NCT06008301

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

State-Trait Anxiety Inventory (STAI)

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

State-Trait Anxiety Inventory (STAI)

Intervention Type OTHER

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

Interventions

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State-Trait Anxiety Inventory (STAI)

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Breast Cancer Alliance

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordana Phillips, MD FSBI

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Dept of Radiology

Other Identifiers

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H-44009

Identifier Type: -

Identifier Source: org_study_id

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