MarginProbe 2.0 Data Collection Protocol

Breast Cancer Clinical Trial

Official title:

MarginProbe 2.0 Data Collection Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377229
• Other study ID #: CP-13-001
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Dilon Technologies Inc.
• Contact: Maya Livnat
• Phone: +972.4.617.8000
• Email: mlivnat[@]dilon.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system.

In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women over 18 years of age

2. Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure

3. Signed Informed Consent Form

Exclusion Criteria:

1. Undergoing re-excision procedure

2. Concurrent infectious disease

3. Pregnancy

4. Lactation

5. Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast

6. Prior radiation treatment in the operated breast

7. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• MarginProbe2.0
The MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
United States	Health and Hospitals Corporation/Kings County	Brooklyn	New York
United States	Mercy Medical Center	Cedar Rapids	Iowa
United States	Englewood Health	Englewood	New Jersey
United States	Glendale Adventist Medical Center	Glendale	California
United States	Logan Health Breast Center	Kalispell	Montana
United States	Northwell Northern Westchester	Mount Kisco	New York
United States	Northwell Health	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dilon Medical Technologies Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse Events (AEs) and Serious Adverse Events (SAEs)	During the lumpectomy surgery
Primary	Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.	The cohorts will continue to be collected until a final algorithm is established and the cohort(s) can be collected with the final algorithm to determine the sensitivity and specificity to demonstrate non-inferiority to the MP1.x system.	During the lumpectomy surgery