- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576106
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy (CRYOSE01)
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lyon, France, 69008
- Centre Leon Berard
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
- 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:
- Invasive lobular carcinoma
- Tumor with retro-nipple location
- Extended microcalcifications (> 15 mm) with mammography
- Xylocaine allergy
- Patient deprived of freedom
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryoablation
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of success of cryoablation procedure
Time Frame: 45 days after cryoablation
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percentage of viable cells in the piece of lumpectomy
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45 days after cryoablation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Pilleul, MD-PhD, Centre Leon Berard
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ET15-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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