Improving Characterization of Calcifications With Contrast-Enhanced Mammography

NCT03639129 | Withdrawn DMC FDA Device

• 1 other identifier: 201709088
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mammography

Outcome Measures

Primary Outcomes (1)

• Evaluate risk characterization of screen-detected calcifications by CEM

  -The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)

  Up to 30 days after the CEM

Secondary Outcomes (3)

• Rate of detection of additional sites of disease in the same or contralateral breast on CEM

  At the time of the CEM (day 1)

• Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density

  At the time of the CEM (day 1)

• Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography

  At the time of the CEM (day 1)

Study Arms (1)

Contrast-enhanced mammography (CME)

EXPERIMENTAL

-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.

Device: Contrast-enhanced mammography; Procedure: Biopsy

Interventions

Contrast-enhanced mammography 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

Also known as: CME

Contrast-enhanced mammography (CME)

Biopsy PROCEDURE

Standard of care

Contrast-enhanced mammography (CME)

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Matthew Covington, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 20, 2018
• Study Start: May 31, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share