RECRUITING

Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device

Conditions

Breast Screening CEM Contrast-Enhanced Mammography Contrast Diagnostic mammogram Mammography Mammogram

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device

Quick Facts

Study Start:2024-10-14

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06636539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Muhammad Waqas Director of Global Clinical Affairs

CONTACT

+15088267183

Muhammad.Waqas@hologic.com

Alexis Cooper Senior Manager, Clinical Development-Clinical Affairs

CONTACT

+1281-868-1140

alexis.cooper@hologic.com

Principal Investigator

Chirag Parghi, MD

PRINCIPAL_INVESTIGATOR

Solis Mammography

Study Locations (Sites)

Solis Mammography Memorial Village

Houston, Texas, 77024

United States

Washington Radiology Sterling

Sterling, Virginia, 20166

United States

Collaborators and Investigators

Sponsor: Hologic, Inc.

Chirag Parghi, MD, PRINCIPAL_INVESTIGATOR, Solis Mammography

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-10-14

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

CEM
Contrast-Enhanced Mammography
Contrast
Diagnostic mammogram
Mammography
Mammogram

Additional Relevant MeSH Terms

Breast Screening