Endometrial cancer, uterine cancer
Conditions
Brief summary
Primary endpoint is the feasibility of the SLN procedure using 68-Ga tilmanocept PET/CT in patients with high/high-intermediate riskendometrial cancer. The feasibility is assessed by the SLN detection rate of 68Ga-tilmanocept PET/CT. The SLN detection rate of PET/CT is defined as the detection of a PET-avid node.
Detailed description
- To investigate the correlation between SLN detection rate and anatomical location of SLNs with preoperative 68Ga-tilmanoceptPET/CT versus intraoperative ICG with NIR fluorescence; - To assess pathological status of the SLNs: tumour negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameterbetween 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells);, Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT up to one hour post-PET/CT (graded by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0).
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the feasibility of the SLN procedure using 68-Ga tilmanocept PET/CT in patients with high/high-intermediate riskendometrial cancer. The feasibility is assessed by the SLN detection rate of 68Ga-tilmanocept PET/CT. The SLN detection rate of PET/CT is defined as the detection of a PET-avid node. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To investigate the correlation between SLN detection rate and anatomical location of SLNs with preoperative 68Ga-tilmanoceptPET/CT versus intraoperative ICG with NIR fluorescence; - To assess pathological status of the SLNs: tumour negative, macrometastasis (diameter >2.0 mm), micrometastasis (diameterbetween 0.2 and 2.0 mm) or isolated tumour cells (diameter <0.2 mm or individual tumour cells);, Adverse events related to SLN mapping with 68Ga-tilmanocept PET/CT up to one hour post-PET/CT (graded by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0). | — |
Countries
Netherlands
Outcome results
None listed