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

NCT03561454 | Active Not Recruiting FDA Device

• 1 other identifier: 20180335
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• tumor recurrence

  5 years

Interventions

IORT DEVICE

Intra-Operative Radiation Therapy

Eligibility Criteria

• Age: 40 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female 40 years of age and older receiving IORT treatment

You may qualify if:

• Subject must have provided written Informed Consent
• Subject must have biopsy-proven ductal carcinoma in situ (DCIS) or invasive ductal carcinoma of the breast
• a. In addition to invasive ductal carcinoma, allowable invasive carcinomas are: i. Adenoid cystic (or adenocystic) carcinoma ii. Low-grade adenosquamous carcinoma iii. Medullary carcinoma iv. Mucinous (or colloid) carcinoma v. Papillary carcinoma vi. Tubular carcinoma vii. Metaplastic carcinoma viii. Micropapillary carcinoma ix. Mixed carcinoma
• Subject must be female ≥ 40 years of age
• Subject's tumor(s) must be \< 3.0 cm in greatest diameter by pre-operative assessment
• Clinical staging of Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (\< 3 cm), N0, M0

You may not qualify if:

• Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
• Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
• Subject is pregnant or nursing
• Subject has significant auto-immune disease
• Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
• Subject has multi-focal breast cancer where the sum of the individual tumor sizes (greatest diameters) are \> 3 cm Subject has multi-centric breast cancer
• Subject has known lympho-vascular invasion
• Subject has invasive lobular cancer
• Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
• Subject has a history of recurrent breast cancer in the ipsilateral breast
• Subject has had previous radiation exposure of the involved breast
• Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
• Subject has contraindications for radiation
• Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
• Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT

Sponsors & Collaborators

• MedStar Franklin Square Medical Center: lead
• Medstar Health Research Institute: collaborator

Study Sites (1)

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

Location

Study Officials

• Maen Farha, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: January 11, 2019
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: October 19, 2023

Record last verified: 2023-03

Locations

US (1)