COMPLETED

A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer

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 evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.

Official Title

Feasibility of Automated Breast Ultrasound (ABUS) Versus Handheld Ultrasound (HHUS) for Breast Cancer Surveillance in Women With Nipple Sparing or Skin Sparing Mastectomy With Reconstruction

Quick Facts

Study Start:2022-11-18
Study Completion:2025-02-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05408260

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:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * \>= 18 years of age at time of consent
  3. * Free of focal breast symptoms and with no suspicious breast physical exam findings
  4. * Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital
  5. * Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign
  6. * Willing to comply with all study procedures and be available for the duration of the study
  7. * Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound
  1. * History of breast cancer recurrence
  2. * Current focal breast symptoms since NSM or SSM with reconstruction
  3. * NSM or SSM with reconstruction was performed years prior to study enrollment
  4. * Bilateral NSM or SSM with reconstruction
  5. * Females who are pregnant

Contacts and Locations

Study Locations (Sites)

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

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 Date2022-11-18
Study Completion Date2025-02-17

Study Record Updates

Study Start Date2022-11-18
Study Completion Date2025-02-17

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Breast Neoplasm