Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05218044

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

Led by Glendale Adventist Medical Center d/b/a Adventist Health Glendale · Updated on 2023-03-03

30

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

G

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

Lead Sponsor

H

Helen Rey Breast Cancer Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • DCIS spanning 2 cm or less based on radiographic appearance by mammography and/or breast contrast-enhanced MRI
  • Diagnosis of DCIS by minimally invasive needle biopsy
  • No prior history of DCIS or invasive breast cancer in the same breast
  • No history of surgical biopsy and/or lumpectomy for diagnosis or treatment in the same breast
  • Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes
  • Non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months
  • No history of breast radiation in the same breast
Not Eligible

You will not qualify if you...

  • Male or females with breasts too small to allow safe cryoablation
  • Pregnancy or lactation
  • History of pregnancy within the last 6 months
  • History of breast radiation in the same breast
  • Prior surgical biopsy or lumpectomy in the same breast
  • Prior history of DCIS or invasive breast cancer in the same breast

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Office of Dennis R. Holmes, M.D., F.A.C.S.

Glendale, California, United States, 91206

Actively Recruiting

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Research Team

D

Dennis R Holmes, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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