Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 45988 for:    intensity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126487
Recruitment Status : Withdrawn (study do not start due to concurrential trial)
First Posted : April 24, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: HIGH INTENSITY FOCUSED ULTRASOUND Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : January 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIGH INTENSITY FOCUSED ULTRASOUND
HIGH INTENSITY FOCUSED ULTRASOUND
Procedure: HIGH INTENSITY FOCUSED ULTRASOUND
HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION




Primary Outcome Measures :
  1. Histological analysis of the surgical specimen will identify the tissue destroyed by ultrasound, residual healthy tissue and possibly residual viable cancerous tissue. [ Time Frame: up to 24 months ]
    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


Secondary Outcome Measures :
  1. Early skin toxicity is assessed until surgery [ Time Frame: up to 24 months ]
    clinical examination (radiation oncologist) using NCI-CTCAE version 4.03 for erythema, telangiectasia and edema,

  2. 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. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Woman with invasive unifocal and unilateral noninflammatory ductal breast cancer.
  2. Age> 18 years.
  3. Size ≤ 10 mm (measured by MRI).
  4. Histological confirmation of breast cancer by biopsy with sufficient material to estimate grade, hormonal status and HER2 status.
  5. Lesion well delineated in MRI after injection of gadolinium and certain ultrasound correlation with the biopsy lesion.
  6. Distance> 10 mm between the tumor and the skin and between the tumor and the muscle.
  7. Performance status 0 or 1
  8. 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

  9. Informing the patient or her legal representative and signing the informed consent
  10. Patient with Health care insurance available

Exclusion Criteria:

  1. Invasive lobular carcinoma or extensive in-situ component or only presence of micro-calcifications as a disease sign
  2. MRI or uncorrelated ultrasound lesion
  3. Distance <10 mm between the tumor and the skin or nipple or chest cage or muscle
  4. PS <2
  5. Patient weighing more than 110 Kg
  6. Breast Implants
  7. History of breast irradiation
  8. History of surgery on the breast to be treated (fibrous scar, staples or surgical clips)
  9. Treatment with antiaromatase, tamoxifen or neoadjuvant chemotherapy within 30 days of treatment start
  10. History of severe cerebrovascular disease (cerebrovascular accident within 6 months prior to inclusion) or hemolytic anemia (hematocrite <30)
  11. Patient with cardiac disorders (severe hypertension, antiarrhythmic treatments, history of cardiac ischemia) 1

2. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126487


Locations
Layout table for location information
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Layout table for investigator information
Study Director: CHRISTINE LOVERA, MRS CENTRE ANTOINE LACSSAGNE

Layout table for additonal information
Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT03126487     History of Changes
Other Study ID Numbers: 2015/36
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases