RECRUITING

Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

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

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.

Official Title

Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

Quick Facts

Study Start:2021-11-01
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05218044

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. * DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI
  2. * Diagnosis of DCIS by minimally invasive needle biopsy
  3. * No prior history of DCIS or invasive breast cancer in the same breast
  4. * No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast
  5. * Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes male and females with breasts too small to allow safe cryoablation
  6. * Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
  7. * No history of breast radiation in the same breast
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Dennis R Holmes, M.D.
CONTACT
800-203-5515
drholmesmd50@gmail.com

Study Locations (Sites)

Office of Dennis R. Holmes, M.D., F.A.C.S.
Glendale, California, 91206
United States

Collaborators and Investigators

Sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale

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 Date2021-11-01
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

  • DCIS

Additional Relevant MeSH Terms

  • Ductal Carcinoma in Situ