Brain metastases
Conditions
Brief summary
Based upon the primary objective: “To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin” we propose the following primary endpoint: Concordance rate between the pathology results with respect to the presence of cancer and the imaging assessment. This endpoint is chosen as this study serves as a proof of principle.
Detailed description
Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status., 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., Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue., - 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 o Glasgow Coma Scale o Monitoring of unpredicted seizures o Monitoring of unpredicted focal deficits
Interventions
DRUGSGM-101
Sponsors
Academisch Ziekenhuis Leiden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Based upon the primary objective: “To assess the performance of SGM-101 in the intraoperative detection of brain metastases of colorectal origin” we propose the following primary endpoint: Concordance rate between the pathology results with respect to the presence of cancer and the imaging assessment. This endpoint is chosen as this study serves as a proof of principle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status., 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., Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue., - 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 o Glasgow Coma Scale o Monitoring of unpredicted seizures o Monitoring of unpredicted focal deficits | — |
Countries
Netherlands
Outcome results
None listed