Colorectal brain metastases MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10055093 Term: Brain cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Fluorochrome-labeled anti-carcinoembryonic antigen
Product Code: SGM-101
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: SGM-101
Other descriptive name: Chimeri
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 6. History of any anaphylactic reaction; 7. Previous use of SGM-101; 8. 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; 9. Laboratory abnormalities defined as: a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or; b. Total bilirubin above 2 times the ULN or; c. Serum creatinine above 1.5 times the ULN or; d. Platelet count below 100 x 109/L or; e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); f. 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; 10. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate); 11. 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints - Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue - 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. Safety and tolerability endpoints - 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;Timepoint(s) of evaluation of this end point: During the infusion day, during surgery and 2 weeks after surgery when the pathology results are expected. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases - Concordance between fluorescent signal and tumor status of resected tissue;Secondary Objective: 2. To assess the number of intraoperative changes in surgical plan based on fluorescence - To assess the relationship between intraoperative changes and pathological status of the resected tissue 3. To determine the Tumor-to-background ratio (TBR); 4. To determine the tolerability and safety of SGM-101;Primary end point(s): Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status.;Timepoint(s) of evaluation of this end point: After 2 weeks, when the pathology results are expected. | — |
Countries
Netherlands
Contacts
Public ContactAlexander Vahrmeijer
Leiden University Medical Center
Outcome results
None listed