Intra-Operative Radiation Registry

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994067
• Other study ID #: 2018-9409
• Status: Recruiting
• Start date: August 9, 2018
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Albert Einstein College of Medicine
• Contact: Jana Fox, MD
• Phone: 718-920-4140
• Email: jfox[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

Eligible patients will be referred for radiation oncology consultation by the operating surgeon. Patients will be presented with all radiation options and if they choose IORT, they will be offered enrollment onto the registry trial and consented accordingly. The registry will collect treatment data from the operation, radiation and pathology notes post IORT for each patient enrolled. Sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. No additional tissue will be collected from patients due to enrollment on this registry trial. No additional studies will be performed outside of the routine standard of care.

Post treatment, the registry will collect data based on the standard of care follow up schedule. Follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. Patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. Additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following IORT. Toxicity will be scored using CTCAE v4.03. Local control will be evaluated using clinical exam and semi-annual to annual mammograms. All such information will be tracked and recorded into the registry database.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion 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

Exclusion criteria

• 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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Moses Campus	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with locally controlled disease	How many patients have recurrent disease following intra-operative radiation	5 years following radiation therapy
Primary	Number of patients with regionally controlled disease	How many patients have recurrent nodal disease following intra-operative radiation	5 years following radiation therapy
Primary	Number of patients with grade 2 or higher toxicities	How many patients have toxicity as measured by the CTCAE	5 years following radiation therapy