A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Medical Center Haaglanden
RECRUITING
The Hague
Contact Information
Primary
Mats Warmerdam, MD
m.i.warmerdam@lumc.nl
+31 71 5265 401
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 10
Treatments
Experimental: Patients with colorectal brain metastases
10 mg SGM-101, administration 3 to 5 days prior to surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Surgimab, Medical Center Haaglanden
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov

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