polyp rectal cancer
Conditions
Interventions
In total 20 patients will be included. The first 3 patients with large rectal
polyps in the distal and mid-rectum scheduled for a local endoscopic en-bloc
resection, will receive a single dose of 10
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patient must have suspected HGD/T1RC and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano. 2. Age > 18 years old 3. Patients should be capable and willing to give signed informed consent before study specific procedures.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study 1. Prior participation in this study 2. Previous administration of SGM-101 3. Patients with a history of anaphylactic shock 4. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential 5. Any condition that the investigator considers to be potentially jeopardizing the patients* well-being or the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I/2: Primary endpoint is the ex-vivo fluorescence TDR (T1RC/HGD to LGD ratio). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective) on whole specimen (Quest open camera, PEARL), bread loafs (Quest open camera and PEARL) and slides (dedicated 700nm microscopy scanner) - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope. - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo on whole specimen (Quest open camera, PEARL), bread loafs (Quest open camera and PEARL) and slides (dedicated 700nm microscopy scanner). A TDR of >=1,5 is defined as true positive. A TDR of | — |
Countries
Netherlands
Outcome results
None listed