Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection

Breast Cancer Clinical Trial

Official title:

Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection (ELINORE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020573
• Other study ID #: 2020-02
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Erbe Elektromedizin GmbH
• Contact: Vanessa Hartmann
• Phone: +4970717552850
• Email: vanessa.hartmann[@]erbe-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection.

In consequence the data should also be taken to adapt technical features according to the findings. The study results will be utilized to design and to calculate the sample size for future pivotal studies after finalizing this study and to adapt the technical features of the system and/ or device. In the future pivotal study, the effectiveness of method and the reduction in R1 resection rate will be assessed with the final goal to provide continuous or real-time information about the tissue type that is currently cut.

The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.

After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. During the second visit (V2) they will receive the treatment procedure with the investigational medical device (IMD). The follow up visit (V3) will be performed up to 7 days after the treatment procedure at the day of discharge from the hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)

2. Solid tumor size = 15 mm at screening, on sonography imaging

3. Breast conserving surgery

4. = 18 years of age

5. Ability to provide written informed consent

Exclusion Criteria:

1. Neoadjuvant chemotherapy

2. Bilateral breast conserving surgery

3. Invasive lobular carcinoma, DCIS, LCIS

4. Suspicion of extensive DCIS component of NST tumor

5. Diagnosis of recurrent breast cancer

6. Previous radiotherapy

7. Patient is pregnant or lactating

8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator

9. According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Resection Margin

Intervention

Device:
• Clip-on electrode with fiber optics
The device will be used for tumor resection of breast cancer and for the collection of optical data that could be ultimately used for providing additional information.

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
Erbe Elektromedizin GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Spether D, Scharpf M, Hennenlotter J, Schwentner C, Neugebauer A, Nussle D, Fischer K, Zappe H, Stenzl A, Fend F, Seifert A, Enderle M. Real-time tissue differentiation based on optical emission spectroscopy for guided electrosurgical tumor resection. Biomed Opt Express. 2015 Mar 24;6(4):1419-28. doi: 10.1364/BOE.6.001419. eCollection 2015 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, feasibility and performance	The primary endpoint for this first in human feasibility study is the percentage of patients with no serious adverse event related to the investigational device.	11 days