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Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy


N/A
18 Years
N/A
Not Enrolling
Female
Breast Tumor

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Trial Information

Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy


The treatment consists of tumor ablation by USF, guided by MRI, performed under local
anesthesia and sedation. Patients will be operated (mastectomy) from 48 hours after
ablation.


Inclusion Criteria:



- Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis,
the grade of the tumor, the expression of Her-2.

- Lesion classified T1-T2-T3 unifocal or multifocal with or without associated
microcalcifications

- Lesion recognizable and identifiable in MRI

- Indication of mastectomy with or without axillary

- Lesion located more than 10 mm from the skin, the nipple and pectoralis major

- No cons-indication to MRI (pacemaker)

- Women whose age is ≥ 18 years

- If premenopausal patient: patient contraceptives

- Patient has signed informed consent

- Affiliation to a social security scheme

Exclusion Criteria:

- Tumor-TD T4B classified or non-palpable lesion

- If age <70 years: no indication of adjuvant chemotherapy and neoadjuvant

- MRI lesions have not been identified, located within 10 mm of the skin and pectoral
muscle, greater than 25 mm diameter

- Inability to hold still in the prone position, arms extended, for 30 minutes

- Contraindication to MRI

- Patient deprived of liberty and major subject of a measure of legal protection or
unable to consent

- Patient participating in another interventional clinical trial within 30 days prior
to baseline and during the trial.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Evaluate the effectiveness of ablathermy

Outcome Description:

Evaluate the effectiveness of ablathermy focused ultrasound breast tumors on histological criteria in terms of destruction of the tumor mass by coagulation necrosis

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

PALUSSIERE Jean, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IB2009-58

NCT ID:

NCT01827969

Start Date:

December 2009

Completion Date:

March 2011

Related Keywords:

  • Breast Tumor
  • Women
  • breast tumor
  • planned mastectomy
  • Breast Neoplasms

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