Clinical trial · Interventional
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Fibroadenoma | Breast Fibroadenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExAblate 2000 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- treatment/ablation of breast fibroadenoma
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Gender: Females only * Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy. * Single tumor per breast quadrant * Tumor clearly visible on non-contrast MRI * Age \> 18 years 3.2.6 Signed informed consent * Tumor 5 mm or larger as measured on pre-treatment MR. Exclusion Criteria: * Gender: male * Focal breast lesion on MRI over 3.5 cm as evaluated by MRI * Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm. * Microcalcifications within the lesion * Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis. * Hemolytic anemia (hematocrit\<30) * Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Severe hypertension (diastolic BP \> 100 on medication) * Patients with cardiac pacemakers * ASA Score\>2 * Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 3.3.12 Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 3.3.13 Patients with breast implants * Large patients who cannot fit in the magnet (weight\>250 pounds), and patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices * Patients on anti-coagulation therapy, or those with an underlying bleeding disorder. * Patient has a prior history of breast cancer * Patient has a prior history of laser or radiation therapy to the target breast * Patient has a prior history of chemo therapy
References
Publications (0)
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