A feasibility study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of colorectal brain metastases.

Phase 2

Recruiting

• Conditions: Brain metastases

• Registration Number: 2024-510767-30-00
• Lead Sponsor: Academisch Ziekenhuis Leiden

Brief Summary

To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Signed informed consent prior to any study-mandated procedure.

Patients aged over 18 years old.

All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.

Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria

History of any anaphylactic reaction; 7. Previous use of SGM-101.

Previous use of SGM-101.

Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.

Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate).

Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Based upon the primary objective: “To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin” we propose the following primary endpoint: Concordance rate between the pathology results with respect to the presence of cancer and the imaging assessment. This endpoint is chosen as this study serves as a proof of principle.		Based upon the primary objective: “To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin” we propose the following primary endpoint: Concordance rate between the pathology results with respect to the presence of cancer and the imaging assessment. This endpoint is chosen as this study serves as a proof of principle.

Secondary Outcome Measures

Name	Time	Method
Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status.		Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status.
Modification of operative plan due to imaging (e.g. extension, reduction of resection margins, or additional resection) and change in postoperative treatment will be recorded.		Modification of operative plan due to imaging (e.g. extension, reduction of resection margins, or additional resection) and change in postoperative treatment will be recorded.
Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue.		Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue.
- Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) o Body temperature o Glasgow Coma Scale o Monitoring of unpredicted seizures o Monitoring of unpredicted focal deficits		- Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) o Body temperature o Glasgow Coma Scale o Monitoring of unpredicted seizures o Monitoring of unpredicted focal deficits

Trial Locations

Locations (2)

Haaglanden Medisch Centrum Stichting; 🇳🇱 Leidschendam, Netherlands

Leids Universitair Medisch Centrum (LUMC); 🇳🇱 Leiden, Netherlands

Haaglanden Medisch Centrum Stichting

🇳🇱Leidschendam, Netherlands

M.L.D. Broekman

Site contact

+31889797900

m.broekman@haaglandenmc.nl