Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
NCT ID: NCT02576106
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2016-02-29
2020-01-31
Brief Summary
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The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cryoablation
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
Cryoablation
Interventions
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Cryoablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Menopausal women with age \> 55 years
* Tumor size \<= 15 mm by ultrasonography
* Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis \& Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
* Good lesion boundary with ultrasonography and MRI
* Minimal distance of 5 mm between the skin and the tumor
* Performance Status 0-1
* Ability to understand and willingness to sign a written informed consent document
* Covered by a medical insurance
* Signed informed consent
Exclusion Criteria
* Tumor with retro-nipple location
* Extended microcalcifications (\> 15 mm) with mammography
* Xylocaine allergy
* Patient deprived of freedom
55 Years
FEMALE
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Frank Pilleul, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Léon Bérard
Lyon, , France
Countries
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Other Identifiers
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ET15-001
Identifier Type: -
Identifier Source: org_study_id
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