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Intraoperative Radiotherapy for Early Stage Breast Cancer

NCT01189851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-15

No results posted yet for this study

Summary

Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

Conditions

Interventions

DEVICE

Intraoperative Radiotherapy

The Axxent eBx™ System utilizes a miniaturized high dose rate (HDR) X-ray source to apply radiation directly to the cancerous tumor bed and provides brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

Sponsors & Collaborators

  • Hoag Memorial Hospital Presbyterian

    lead OTHER

Principal Investigators

  • Peter V Chen, MD · Hoag Memorial Hospital Presbyterian

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2023-09-30
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01189851 on ClinicalTrials.gov