NCT04871139

Brief Summary

This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Apr 2021Mar 2028

Study Start

First participant enrolled

April 8, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6.9 years

First QC Date

May 1, 2021

Last Update Submit

March 25, 2026

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Accuracy of contrast-enhanced mammography (CEM)

    Will examine the accuracy of CEM compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with mammographic architectural distortion (MAD)s.

    Up to 3 years

Secondary Outcomes (7)

  • Sensitivity of CEM, FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS

    Up to 3 years

  • Specificity of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS

    Up to 3 years

  • Negative predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS

    Up to 3 years

  • Positive predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS

    Up to 3 years

  • Degree of enhancement on CEM

    Up to 3 years

  • +2 more secondary outcomes

Study Arms (1)

Diagnostic (iodine-based contrast, CEM)

EXPERIMENTAL

Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.

Procedure: BiopsyProcedure: Contrast-Enhanced MammographyOther: Questionnaire AdministrationOther: Radioactive Iodine

Interventions

BiopsyPROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx
Diagnostic (iodine-based contrast, CEM)
Questionnaire AdministrationOTHER

Ancillary studies

Diagnostic (iodine-based contrast, CEM)
Contrast-Enhanced MammographyPROCEDURE

Undergo CEM

Also known as: CEM
Diagnostic (iodine-based contrast, CEM)
Radioactive IodineOTHER

Given IV

Diagnostic (iodine-based contrast, CEM)

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC
  • Age 25-85 years
  • Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent

You may not qualify if:

  • Reported history of an allergic reaction to iodinated contrast
  • History of anaphylactic reaction to any substance
  • Renal insufficiency
  • Pregnancy or lactation within 6 months
  • Breast surgery affecting the site of interest within prior 6 months
  • Breast biopsy at the site of interest within the last 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olena Weaver

    M.D. Anderson Cancer Center

    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

May 1, 2021

First Posted

May 4, 2021

Study Start

April 8, 2021

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)