High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer

NCT03126487 | Withdrawn DMC

• 1 other identifier: 2015/36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, prospective phase II trial evaluating an innovative treatment, focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue.

  All surgical specimens will be collected and analyzed in full. The sterility of the surgical specimen will be assessed using the score proposed by the EORTC-STBSG (FUS-MRI) in the local treatment of infra-centimetric breast cancer by histological confrontation of the surgical specimen

  up to 24 months

Secondary Outcomes (2)

• Early skin toxicity is assessed until surgery

  up to 24 months

• The quality of life will be measured before treatment on D0, and during the visit between D21 and D28 using the QLQ-C30 questionnaire - breast module BR23-version 3.

  up to 24 months

Study Arms (1)

HIGH INTENSITY FOCUSED ULTRASOUND

EXPERIMENTAL

HIGH INTENSITY FOCUSED ULTRASOUND

Procedure: HIGH INTENSITY FOCUSED ULTRASOUND

Interventions

HIGH INTENSITY FOCUSED ULTRASOUND PROCEDURE

HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION

HIGH INTENSITY FOCUSED ULTRASOUND

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman with invasive unifocal and unilateral noninflammatory ductal breast cancer.
• Age\> 18 years.
• Size ≤ 10 mm (measured by MRI).
• Histological confirmation of breast cancer by biopsy with sufficient material to estimate grade, hormonal status and HER2 status.
• Lesion well delineated in MRI after injection of gadolinium and certain ultrasound correlation with the biopsy lesion.
• Distance\> 10 mm between the tumor and the skin and between the tumor and the muscle.
• Performance status 0 or 1
• Biological exam according to the following standards:
• Neutrophiles\> 1.5 x 109 / L Hemoglobin\> 9 g / dL Plates\> 100 x 109 / L ASAT - ALAT \<2.5 x ULN Bilirubin \<1.5 x ULN Creatinine \<150 μmol / L and\> 60 μmol / L Clearance\> 30 ml / min
• Informing the patient or her legal representative and signing the informed consent
• Patient with Health care insurance available

You may not qualify if:

• Invasive lobular carcinoma or extensive in-situ component or only presence of micro-calcifications as a disease sign
• MRI or uncorrelated ultrasound lesion
• Distance \<10 mm between the tumor and the skin or nipple or chest cage or muscle
• PS \<2
• Patient weighing more than 110 Kg
• Breast Implants
• History of breast irradiation
• History of surgery on the breast to be treated (fibrous scar, staples or surgical clips)
• Treatment with antiaromatase, tamoxifen or neoadjuvant chemotherapy within 30 days of treatment start
• Patient with cardiac disorders (severe hypertension, antiarrhythmic treatments, history of cardiac ischemia) 1
• \. Patient under dialysis 13. Patient under anti-coagulant treatment 14. Patient refusing surgery or for which surgery is contraindicated 15. Contraindication to the realization of MRI or thermo-ablation treatment 16. Patient has a contraindication to Gadolinium 17. Vulnerable persons are defined in Article L1121-5 to -8: Pregnant women, and nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons admitted without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions Of Article L. 1121-8 and persons admitted to a health or social institution for purposes other than research Persons of legal age who are under protection or who are unable to give their consent

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• CHRISTINE LOVERA, MRS

  CENTRE ANTOINE LACSSAGNE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 24, 2017
• Study Start: April 25, 2017
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

FR (1)