RECRUITING

Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.

Official Title

Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)

Quick Facts

Study Start:2017-01

Study Completion:2024-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03044054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma. 2. Diagnosis of fibroadenoma must be based on: 1. Clinical examination 2. Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance. 3. Histologic confirmation by core needle biopsy. 3. Patient is a candidate for the surgery. 4. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed. 5. The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed. 6. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma. 7. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure). 8. Fibroadenoma is palpable. 9. Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days 10. Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days 11. Patient has signed a written informed consent.	1. Patient is pregnant or nursing. 2. Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women \> 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram. 3. Patient with history of breast cancer or history of laser or radiation therapy to the target breast. 4. Patient with breast implants in the target breast. 5. Patient with a breast cyst within the fibroadenoma to be treated. 6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit. 7. Patient participating in another clinical trial involving an investigational drug, device or biologic.

Inclusion Criteria

Exclusion Criteria

1. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
2. Diagnosis of fibroadenoma must be based on:
1. Clinical examination
2. Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.
3. Histologic confirmation by core needle biopsy.
3. Patient is a candidate for the surgery.
4. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
5. The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.
6. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.
7. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).
8. Fibroadenoma is palpable.
9. Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
10. Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
11. Patient has signed a written informed consent.

1. Patient is pregnant or nursing.
2. Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women \> 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
3. Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
4. Patient with breast implants in the target breast.
5. Patient with a breast cyst within the fibroadenoma to be treated.
6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
7. Patient participating in another clinical trial involving an investigational drug, device or biologic.

Contacts and Locations

Study Contact

Michel NUTA, MD

CONTACT

633404004

michel.nuta@theraclion.com

Principal Investigator

Michel NUTA, MD

STUDY_DIRECTOR

Theraclion

Study Locations (Sites)

Bellevue Hospital Center

New York, New York, 10016

United States

New York Columbia University Medical Center

New York, New York, 10032

United States

Montefiore-Einstein Center for Cancer Care

New York, New York

United States

University of Virginia Health system

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Theraclion

Michel NUTA, MD, STUDY_DIRECTOR, Theraclion

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-01

Study Completion Date2024-11

Study Record Updates

Study Start Date2017-01

Study Completion Date2024-11

Terms related to this study

Keywords Provided by Researchers

HIFU

Additional Relevant MeSH Terms

Breast Fibroadenoma