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High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Bergonié

About this trial

Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.

T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.

Clinical N0.

Bra cup size greater than or equal to B.

Disqualifiers

Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.

Bilateral lesion.

Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.

Unifocal palpable tumor.

Trial design

Design model

Single group

Treatments tested in this trial

  • High Instensity Focused Ultrasound

    Device

    High Intensity Focused Ultrasound guided by MRI

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: High Intensity Focused UltrasoundExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of HIFU for the treatment of breast tumors, based on histological criteria

* Complete success: absence of viable invasive tumor cells on histological analysis. * Incomplete success: Partial tumor destruction of the invasive contingent, unhealthy margins due to underestimation of tumor volume before treatment or imperfect targeting of focused ultrasound. Incomplete successes will be considered as failures. The persistence of an in situ quota alone will be considered as success. * Failure: presence of viable invasive tumor cells in the treated area.

Time frame
Day 30

Secondary outcomes

1

Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone)

Time frame
Day 2, 8
2

Immediate complications of focused ultrasound

Time frame
Day 30
3

Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.

Time frame
Day 0, 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Bergonié

Lead sponsor

Ligue contre le cancer, France

Collaborator

Source ClinicalTrials.gov
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