Brain Cancer, Brain Diseases, Brain Metastases, Brain Neoplasms, Brain Tumor, Colorectal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Disease, Gastrointestinal Neoplasms, Intestinal Disease, Intestinal Neoplasms, Rectal Neoplasms, Rectum Cancer
Conditions
Brief 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.
Interventions
DRUGSGM-101
Fluorescence-guided surgery
Sponsors
Medical Center Haaglanden
Surgimab
Leiden University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases. | Intraoperative | * 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 |
Countries
Netherlands
Contacts
Primary ContactMats Warmerdam, MD
Outcome results
None listed