NCT06636539

Brief Summary

This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
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

First Submitted

Initial submission to the registry

October 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

October 7, 2024

Last Update Submit

October 20, 2025

Conditions

Breast Screening

Keywords

CEMContrast-Enhanced MammographyContrastDiagnostic mammogramMammographyMammogram

Outcome Measures

Primary Outcomes (1)

  • Number of subjects (cases) with lesions

    Number of subjects with contrast-enhanced breast images containing lesions as assessed by radiologists' image quality review

    18 months

Study Arms (1)

CEM Investigational Exam

EXPERIMENTAL
Device: CEM Software in New Mammography Device

Interventions

CEM Software in New Mammography DeviceDEVICE

All subjects enrolled in the study will undergo a CEM exam.

CEM Investigational Exam

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCis gender biological women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is female of any race and ethnicity.
  • Subject is at least 35 years old
  • Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
  • Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them.

You may not qualify if:

  • Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
  • Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
  • Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
  • Subject is pregnant or presumed to be pregnant.
  • Subject is breastfeeding.
  • Subject is actively being treated for cancer of any type with chemotherapy
  • Subject is suspected to be at risk of complications from the iodinated contrast agent. These include contra-indications of standard iodinated contrast agents, such as the subject having renal insufficiency) and the subject being on dialysis.
  • Subject has had a prior reaction to iodinated contrast; thus, a known allergy to iodinated contrast.
  • Subject has had a prior reaction to gadolinium contrast agents; thus, a known allergy to gadolinium contrast.
  • Subject who, based on the physician's judgment, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Solis Mammography Memorial Village

Houston, Texas, 77024, United States

ACTIVE NOT RECRUITING

Washington Radiology Sterling

Sterling, Virginia, 20166, United States

RECRUITING

Study Officials

  • Chirag Parghi, MD

    Solis Mammography

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Waqas Director of Global Clinical Affairs

CONTACT

+15088267183Muhammad.Waqas@hologic.com

Alexis Cooper Senior Manager, Clinical Development-Clinical Affairs

CONTACT

+1281-868-1140alexis.cooper@hologic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 10, 2024

Study Start

October 14, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

To protect participant privacy and comply with the IRB. The IRB did not approved the secondary use of IPD at the time the protocol was approved.

Locations

US(2)