Clinical trial · Interventional
SGM-101 in Colorectal Brain Metastases.
A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.
NCT04755920CI-TRIAL-00076968SGM-CBMunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Diseases | — | UNRESOLVED | — |
| Brain Metastases | — | UNRESOLVED | — |
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Intestinal Disease | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGM-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with colorectal brain metastases
- description
- 10 mg SGM-101, administration 3 to 5 days prior to surgery.
- interventionNames
- Drug: SGM-101
Primary outcomes (1)
- measure
- To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
- timeFrame
- Intraoperative
- description
- * Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; * Concordance between the fluorescent signal and the resection margin with the use of neuronavigation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.