RECRUITING

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

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Conditions

Breast Carcinoma

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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 clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.

Official Title

Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study

Quick Facts

Study Start:2021-04-15
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05056844

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:25 Years to 85 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom
  2. * Age 25-85 years
  3. * Willing to participate in the study and undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent
  1. * Reported history of an allergic reaction to iodinated contrast
  2. * History of anaphylactic reaction to any substance in the absence of a prior history of uneventful administration of iodine-based IV contrast.
  3. * Renal insufficiency
  4. * Pregnancy or lactation within 6 months
  5. * Breast surgery affecting the symptomatic breast within prior 6 months, if it was located within 5 cm from the nipple
  6. * Breast biopsy of the symptomatic breast within the last 2 months, if it was located within 5 cm from the nipple
  7. * Breast MRI performed within 24 months before the patient presented with qualifying symptoms (MRI performed contemporarily with CEM for the evaluation of new symptoms is not an exclusion criterion).
  8. * Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern

Contacts and Locations

Study Contact

Olena Weaver, MD
CONTACT
713-471-3613
ooweaver@mdanderson.org

Principal Investigator

Olena Weaver, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Olena Weaver, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2021-04-15
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2021-04-15
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Carcinoma