Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

NCT02794558 | Completed DMC

• 1 other identifier: BC004
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

Conditions

Breast Cancer

Keywords

Breast Cancer, MRgFus, Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse events

  Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications

  5 years

Secondary Outcomes (1)

• Post treatment local recurrence

  5 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Subjects in this arm are treated once with MRgFUS device

Device: ExAblate MRgFUS

Interventions

ExAblate MRgFUS DEVICE

MR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed. Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment.

Also known as: Focused Ultrasound

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Women age ≥ 18 years with - breast cancer proven by 14-20 G. core needle biopsy of the breast lesion.
• No evidence of cancer at the sentinel/ Axillary node
• Women in whom breast MR imaging identifies a single focal well-demarcated breast lesion less than or equal to 1.5 cm in diameter with stage T1, N0, M0 disease.
• Patient received neoadjuvant care for 4 weeks such as: Hormone replacement therapy or Tamoxifen is permissible where the tumor is less than or equal to 1.5 before neoadjuvant therapy
• Able and willing to give consent and able to attend all study visits.
• Able to communicate sensations during the MRgFUS procedure.
• Life expectancy of 5 years or more.

You may not qualify if:

• Breast cancer which was diagnosed by incisional / excisional biopsy
• Contraindication to MRI (non-MRI compatible implanted metal devices).
• Pregnant or lactating post partum women.
• Prior XRT or laser or cryo-therapy to the target breast.
• Difficulty lying prone and still for up to 210 minutes in the MR unit, e.g., COPD, heart disease, lung disease, sleep apnea or airway problems, severe asthma, severe arthritis, severe claustrophobia.
• 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.
• Patients on anti-arrhythmic drugs.
• Severe hypertension (diastolic BP \> 100 on medication).
• Patients with cardiac pacemakers.
• Immunosuppressed patients, e.g., patients receiving steroids or other immunosuppressive medication, insulin-dependent diabetes mellitus, collagen vascular disease.
• Patients receiving chemotherapy
• Patients with history of grand mal seizures, severe cerebrovascular disease (multiple CVA or CVA within 6 months), hemolytic anemia (hematocrit \< 30), or patients on dialysis.

Sponsors & Collaborators

• InSightec: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hidemi Furasawa, MD

  Managing Director at Breastopia Namba Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2005
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share