Using SGM-101 for imaging colorectal brain metastases during surgery

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

This study is testing if a special dye called SGM-101 can help surgeons see colorectal cancer spread to the brain better during surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 2 sites (Leiden and 1 other locations)
• Trial ID: NCT04755920 on ClinicalTrials.gov

What this trial studies

This study evaluates the use of SGM-101, a monoclonal antibody labeled with a fluorochrome, for enhancing the visibility of colorectal brain metastases during surgical resection. Patients will receive an intravenous injection of SGM-101 3 to 5 days before their scheduled surgery. The goal is to assess the feasibility of using near-infrared fluorescence imaging to improve surgical outcomes. This approach aims to provide surgeons with better visualization of cancerous tissues during the operation.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with diagnosed brain metastases of colorectal origin who are scheduled for surgical resection.

Not a fit: Patients with a history of anaphylactic reactions or other active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could lead to more precise surgical removal of colorectal brain metastases, potentially improving patient outcomes.

How similar studies have performed: While the use of fluorescence imaging in surgery is gaining traction, the specific application of SGM-101 for colorectal brain metastases is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. 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.
4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

1. History of any anaphylactic reaction;
2. Previous use of SGM-101;
3. 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;
4. Laboratory abnormalities defined as:

   1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
   2. Total bilirubin above 2 times the ULN or;
   3. Serum creatinine above 1.5 times the ULN or;
   4. Platelet count below 100 x 109/L or;
   5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
   6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
5. Patients pregnant or breastfeeding;
6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Where this trial is running

Leiden and 1 other locations

• Leiden University Medical Center — Leiden, Netherlands (Recruiting)
• Medical Center Haaglanden — The Hague, Netherlands (Recruiting)

Study contacts

• Study coordinator: Mats Warmerdam, MD

Conditions Rectal Neoplasms; Rectum Cancer; Colorectal Neoplasms; Brain Metastases; Brain Neoplasms; Brain Diseases; Brain Cancer; Brain Tumor