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

NCT05218044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Ductal Carcinoma in Situ

Interventions

PROCEDURE

Cryoablation

The cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Sponsors & Collaborators

  • Helen Rey Breast Cancer Research Foundation

    collaborator UNKNOWN

  • California Oncology Research Institute

    collaborator UNKNOWN

  • Doterra Healing Hands Foundation

    collaborator UNKNOWN

  • Glendale Adventist Medical Center d/b/a Adventist Health Glendale

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218044 on ClinicalTrials.gov