Rectal cancer
Conditions
Brief summary
The primary endpoint is the rate of patients with R0 resections. This endpoint is based on the primary objective of clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent.
Detailed description
Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology., For every removed specimen: rate of false negatives, false positives, true negatives and true positives concerning fluorescence, with histopathology as the gold standard., Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue., Modification of operative plan due to imaging (e.g. more/less extensive resection or adjustment of IORT) and change in postoperative treatment will be recorded., 30-day mortality and 30-day complication rates., 2-year overall survival, 2-year disease free survival and 2-year local recurrence free survival.
Interventions
DRUGSGM-101
Sponsors
Academisch Ziekenhuis Leiden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the rate of patients with R0 resections. This endpoint is based on the primary objective of clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent. | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology., For every removed specimen: rate of false negatives, false positives, true negatives and true positives concerning fluorescence, with histopathology as the gold standard., Tumor to background ratio (TBR) for fluorescence in malignant and benign tissue., Modification of operative plan due to imaging (e.g. more/less extensive resection or adjustment of IORT) and change in postoperative treatment will be recorded., 30-day mortality and 30-day complication rates., 2-year overall survival, 2-year disease free survival and 2-year local recurrence free survival. | — |
Countries
Netherlands
Outcome results
None listed