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A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients

NCT03561454 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-10-19

No results posted yet for this study

Summary

Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up. The results of this single arm study will be compared to whole breast irradiation (WBI).

Conditions

  • Early Stage Breast Cancer

Interventions

DEVICE

IORT

Intra-Operative Radiation Therapy

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • MedStar Franklin Square Medical Center

    lead OTHER

Principal Investigators

  • Maen Farha, MD · Medstar Health Research Institute

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2028-08-01
Completion
2029-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03561454 on ClinicalTrials.gov