Clinical trial NCT05377229: MarginProbe 2.0 Data Collection Protocol
Official title: MarginProbe 2.0 Data Collection Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: MarginProbe
Breast Cancer
Lumpectomy
Lead sponsor: Dilon Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include measurements in cohorts of a minimum of 50 subjects up to a maximum of 1000 cases from women, aged 18 and above, undergoing breast lumpectomy/partial mastectomy surgery for previously diagnosed breast cancer.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: During the lumpectomy surgery
measure: Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.
timeFrame: During the lumpectomy surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Cedar Rapids
country: United States
facility: Mercy Medical Center
state: Iowa
city: Kalispell
country: United States
facility: Logan Health Breast Center
state: Montana
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Brooklyn
country: United States
facility: Health and Hospitals Corporation/Kings County
state: New York
city: Mount Kisco
country: United States
facility: Northwell Northern Westchester
state: New York
city: Staten Island
country: United States
facility: Northwell Health
state: New York
city: Bethlehem
country: United States
facility: Lehigh Valley
state: Pennsylvania
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: