RECRUITING

Intra-Operative Radiation Registry

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Conditions

Breast Cancerintraoperative radiation therapypartial breast irradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 partial breast irradiation (PBI) per the latest American Society of Radiation Oncology (ASTRO) guidelines.

Official Title

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

Quick Facts

Study Start:2018-08-09
Study Completion:2032-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04994067

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female gender
  2. * Age ≥ 45
  3. * 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
  4. * Suitable for breast conserving surgery
  5. * No contraindication to radiation
  6. * Mammogram within 6 months of planned procedure
  7. * Fitness for lumpectomy under general anesthesia
  8. * Planned to receive IORT
  9. * Known axillary lymph node positive breast cancer (negative biopsy not required)
  10. * 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.
  11. * Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene
  12. * Patients undergoing neoadjuvant chemotherapy
  13. * Pregnancy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jana Fox, MD
CONTACT
718-920-4140
jfox@montefiore.org

Principal Investigator

Jana Fox, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Jana Fox, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-09
Study Completion Date2032-08

Study Record Updates

Study Start Date2018-08-09
Study Completion Date2032-08

Terms related to this study

Keywords Provided by Researchers

  • intraoperative radiation therapy
  • partial breast irradiation

Additional Relevant MeSH Terms

  • Breast Cancer