Rectal cancer
Conditions
Brief summary
Group A: Diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of 1 or more LNM compared to final pathology after TME, defined as sensitivity and specificity., Group B: Rate of false-positive LNM on [68Ga]Ga-FAPI-46 PET/CT after local excision, defined as one or more suspected lymph nodes on [68Ga]Ga-FAPI-46 PET/CT that reveal no malignant cells on final histopathology after completion TME.
Detailed description
Per-lesion analysis of the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of LNM compared to final pathology after TME., Percentage of agreement between tumor uptake in the lymph nodes on the [68Ga]Ga-FAPI-46 PET/CT scan, histopathologic evidence of tumor in the lymph nodes, and the expression of FAP on immunohistochemistry (IHC)., Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT., Difference in diagnostic accuracy for staging rectal cancer between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT versus regular CT and MRI., Diagnostic incidence of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT., Diagnostic accuracy of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT.
Interventions
Sponsors
Amsterdam UMC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group A: Diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of 1 or more LNM compared to final pathology after TME, defined as sensitivity and specificity., Group B: Rate of false-positive LNM on [68Ga]Ga-FAPI-46 PET/CT after local excision, defined as one or more suspected lymph nodes on [68Ga]Ga-FAPI-46 PET/CT that reveal no malignant cells on final histopathology after completion TME. | — |
Secondary
| Measure | Time frame |
|---|---|
| Per-lesion analysis of the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of LNM compared to final pathology after TME., Percentage of agreement between tumor uptake in the lymph nodes on the [68Ga]Ga-FAPI-46 PET/CT scan, histopathologic evidence of tumor in the lymph nodes, and the expression of FAP on immunohistochemistry (IHC)., Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT., Difference in diagnostic accuracy for staging rectal cancer between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT versus regular CT and MRI., Diagnostic incidence of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT., Diagnostic accuracy of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT. | — |
Countries
Netherlands
Outcome results
None listed