Oral cancer
Conditions
Brief summary
The sensitivity and negative predictive value of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB. Furthermore, the sensitivity and negative predictive value for preoperative 68Ga-Tilmanocept PET/CT alone will be compared with conventional preoperative lymphoscintigraphy alone.
Detailed description
To compare the number of 68Ga-Tilmanocept PET-CT detected SLNs with those detected by means of 99mTc-Tilmanocept lymphoscintigraphy on a per-subject basis., To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET-CT., Observing contralateral drainage patterns in lateralized tumors and compare these patterns between of 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy, especially in case of a histopathological positive sentinel node., To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection.
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and negative predictive value of 68Ga-Tilmanocept PET/CT combined with conventional lymphoscintigraphy for SLNB. Furthermore, the sensitivity and negative predictive value for preoperative 68Ga-Tilmanocept PET/CT alone will be compared with conventional preoperative lymphoscintigraphy alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the number of 68Ga-Tilmanocept PET-CT detected SLNs with those detected by means of 99mTc-Tilmanocept lymphoscintigraphy on a per-subject basis., To compare histopathologic assessment (presence or absence of metastasis) of the excised lymph node(s) detected by conventional preoperative 99mTc-Tilmanocept lymphoscintigraphy and intraoperative gammaprobe localization, with the SLNs identified by means of preoperative 68Ga-Tilmanocept PET-CT., Observing contralateral drainage patterns in lateralized tumors and compare these patterns between of 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy, especially in case of a histopathological positive sentinel node., To assess pairwise inter-observer agreements between 68Ga-Tilmanocept PET-CT and 99mTc-Tilmanocept lymphoscintigraphy regarding preoperative SLN detection. | — |
Countries
Netherlands
Outcome results
None listed