Intra-Operative Radiation Registry

Description

This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable PBI per the latest ASTRO guidelines.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable PBI per the latest ASTRO guidelines.

Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol

Intra-Operative Radiation Registry

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center - Moses Campus, Bronx, New York, United States, 10467-2490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female gender
  • * Age ≥ 45
  • * cT1-2N0, \<3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, \< 2.5 cm, estrogen-receptor positive
  • * Suitable for breast conserving surgery
  • * No contraindication to radiation
  • * Mammogram within 6 months of planned procedure
  • * Fitness for lumpectomy under general anesthesia
  • * Planned to receive IORT
  • * Known axillary lymph node positive breast cancer (negative biopsy not required)
  • * Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
  • * Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene
  • * Patients undergoing neoadjuvant chemotherapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Albert Einstein College of Medicine,

Jana Fox, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2029-08