Improving Characterization of Calcifications With Contrast-Enhanced Mammography

NCT ID: NCT03639129

Last Updated: 2019-05-14

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WITHDRAWN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

2019-05-31

Study Completion Date

2021-05-31

Brief Summary

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The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.

Detailed Description

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Conditions

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Mammography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contrast-enhanced mammography (CME)

-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM.

Group Type EXPERIMENTAL

Contrast-enhanced mammography

Intervention Type DEVICE

Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world

Biopsy

Intervention Type PROCEDURE

Standard of care

Interventions

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Contrast-enhanced mammography

Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world

Intervention Type DEVICE

Biopsy

Standard of care

Intervention Type PROCEDURE

Other Intervention Names

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CME

Eligibility Criteria

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Inclusion Criteria

* Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
* At least 30 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document
* GFR ≥ 30 mL/min/1.73 m2

Exclusion Criteria

* Pregnant
* Prior history of allergy or hypersensitivity reaction to iodinated contrast
* History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
* Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Covington, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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201709088

Identifier Type: -

Identifier Source: org_study_id

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