RECRUITING

Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

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

Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

Official Title

Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Quick Facts

Study Start:2022-10-10
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05456373

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. 1. Patients who are female (genotype)
  2. 2. Patients aged above 18 years, inclusive
  3. 3. Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
  4. 4. Patients treated with neoadjuvant endocrine therapy may be enrolled
  1. 1. Patients currently receiving chemotherapy
  2. 2. Patients having prior ipsilateral surgical treatment for breast cancer
  3. 3. Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma)
  4. 4. Patients who have breast implants
  5. 5. Patients who are pregnant and/or lactating
  6. 6. Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.

Contacts and Locations

Study Contact

Moshe Sarfaty, PhD
CONTACT
408-464-4051
moshe@lsbiopath.com
Catherine Kusnick, MD
CONTACT
9496369601
ckusnick@alum.wellesley.edu

Principal Investigator

Jasmine Wong, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco Medical Center

Study Locations (Sites)

UCSF Medical Center at Mission Bay
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: LS BioPath

  • Jasmine Wong, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco Medical 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 Date2022-10-10
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-10-10
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • lumpectomy
  • positive surgical margins

Additional Relevant MeSH Terms

  • Breast Cancer