Health TrialsbyHealthPanel

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

ConditionDuctal Carcinoma in Situ
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGlendale Adventist Medical Center d/b/a Adventist Health Glendale

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

DCIS spanning 2 cm or less based on its 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/treatment in the same breast

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryoablation

    Procedure/Surgery

    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 After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CryoablationOther 1 intervention

Trial outcomes

Primary outcomes

1

Ability of cryoablation to achieve complete ablation of DCIS

Number of participants to achieve completeness of ablation by measuring the percentage of subjects with no residual DCIS or invasive cancer within the zero of necrosis assessed in the post-cryoablation core biopsy obtained 6 months post-cryoablation.

Time frame
6 months

Secondary outcomes

1

Recurrence rate

Number of participants at the 5-year rate of invasive breast cancer recurrence after cryoablation of DCIS measuring \</= 2cm.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Lead sponsor

Helen Rey Breast Cancer Research Foundation

Collaborator

California Oncology Research Institute

Collaborator

Doterra Healing Hands Foundation

Collaborator

Source ClinicalTrials.gov
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