NCT01620359

Brief Summary

The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI. The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2011

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

5.1 years

First QC Date

June 13, 2012

Last Update Submit

August 29, 2016

Conditions

Breast Cancer

Keywords

Breast cancerBreast tumorstage 1 diseaseT1 M0 N0

Outcome Measures

Primary Outcomes (2)

  • Adverse Events

    To evaluate the incidence and severity of the ExAblate MRgFUS device-related complications to establish the safety profile of the ExAblate ablation of breast cancer visible on contrast-enhanced MRI with 5-10 mm margins around the primary tumor

    5 weeks post treatment

  • Histopathological analyses

    To estimate the effectiveness of ExAblate MRgFUS to ablate 100% of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor.

    5 weeks post treatment

Secondary Outcomes (1)

  • MR imaging

    5 weeks post treatment

Study Arms (1)

ExAblate

EXPERIMENTAL
Device: ExAblate MRgFUS

Interventions

ExAblate MRgFUSDEVICE

100% ablation of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor

ExAblate

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 18 years with invasive breast cancer
  • Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter
  • Lesion clearly seen on contrast-enhanced MR and in a treatable location
  • Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy
  • Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer
  • Patient with clinical Stage I disease: T1 M0 N0
  • Patient who signs an informed consent form for screening, SLNB, ablation, and follow-up visits.

You may not qualify if:

  • Invasive lobular carcinoma;
  • DCIS without invasive components on core biopsy;
  • Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to ExAblate.
  • Prior XRT or ablative therapy to the target breast;
  • Patients currently receiving anticoagulation therapy within the previous 14 days;
  • Lesions difficult to target (\<1 cm from skin, nipple or the rib cage), as visualized on pre-therapy MRI;
  • Microcalcifications as the only sign of breast cancer on imaging studies;
  • Extensive intraductal components (EIC) on core biopsy.
  • Patients with breast implants;
  • Patients with prior surgical clips or other markers at the site of the breast tumor;
  • Patients with severe cerebrovascular disease (multiple CVA or CVA within 6 months);
  • hemolytic anemia (hematocrit \< 30);
  • Pregnant or lactating, post-partum women;
  • Patient overall health status of ASA \>2
  • Patient with active and ongoing infection at any body site;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marienhospital

Bottrop, 46236, Germany

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsDisease

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hans Kolberg, MD

    FUS BOTTROP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

June 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

DE(1)