An interventional study of Intraoperative Radiotherapy in Breast Cancer, sponsored by Hoag Memorial Hospital Presbyterian. Completed at 1 site in United States. Open to female participants aged 48 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Hoag Memorial Hospital Presbyterian · Not applicable, Interventional, and Treatment
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.
Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and CE-MRI and is thought to be resectable with WLE and clear surgical margins, with clinically staged N0M0 disease, minimum age of 48, and histology of invasive ductal or lobular carcinoma of the breast. The lesion size determined by imaging will be compared with lesion size and surgical margin status obtained from the surgical pathology specimen to evaluate the ability of mammography combined with ultrasound and CE-MRI to identify suitable candidates for immediate IORT.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Treated with Intraoperative Radiation Therapy
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.
Also known as: 510(k) Number K050843, Axxent™ Electronic Brachytherapy System
Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment
Invasive cancer margins \<1 mm and/or non-invasive cancer margins \< 2 mm are considered close or positive. Approximately 15% of patients treated with IORT have close or positive margins on pathologic assessment following IORT therapy and are recommended for additional therapy including re-excision, whole breast radiation or both.
Time frame: 10 years
Proportion of Participants Recommended to Have Additional Whole Breast Radiation Therapy (WBRT) Because of High Risk Features Found on Final Pathology as a Measure of the Accuracy of Pre-Operative Assessment
Patients treated with IORT that have high risk features on final pathologic exam, including close/positive margins, tumor size \>30 mm, positive lymph nodes and lympho-vascular invasion (LVI) are recommended for additional therapy including re-excision, whole breast radiation or both.
Time frame: 5 years
Proportion of Participants with Tumor Size Larger than the Entry Criteria Size and/or Positive Lymph Nodes as a Measure of the Accuracy of Pre-Operative Assessment
Both tumor size and lymph node status are estimated prior to surgery using mammography, ultrasound and MRI (unless excluded for medical reasons). Patients with estimated tumor spans \> 30 mm or positive lymph nodes are excluded from IORT.
Time frame: 5 years
Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm
We will be monitoring acute side effects attributed directly to IORT. These includ erythemia, hyperpigmentation, fibrosis, seromas, infection and wound breakdown.
Time frame: 5 years
Cosmesis Scores by Physician and Self-Assessment
The first 213 IORT patients treated will be asked to fill out a yearly cosmesis assessment. Patients filled out these assessments for an average of 2-3 years.
Time frame: 5 years
Progression Free Survival in the First Five Years
We will follow progression free survival for 5 years
Time frame: 5 years
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hoag Memorial Hospital Presbyterian