RecruitingNot ApplicableNCT05218044

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


Sponsor

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

Enrollment

30 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cryoablation — a minimally invasive procedure that uses extreme cold to destroy abnormal tissue — can be used instead of surgery for women with a small area of ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer confined to the milk ducts. **You may be eligible if...** - You have been diagnosed with DCIS measuring 2 cm or less (confirmed by biopsy) - You have no prior history of DCIS or invasive breast cancer in the same breast - You have not had prior surgical biopsy or lumpectomy in the same breast - You have enough breast volume for the procedure to be safely performed - You are not pregnant or breastfeeding and have not been pregnant in the past 6 months **You may NOT be eligible if...** - You have had previous radiation to the same breast - You have a breast that is too small for safe cryoablation - You have a history of invasive breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECryoablation

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.


Locations(1)

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

Glendale, California, United States

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NCT05218044


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