FARE Trial
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Amsterdam UMCAmsterdam, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC
- Trial code
- EU 2023-506594-35-00
- Record updated
- 2025. december 10.
- Original description
Group A: Diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of one 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.Read full original descriptionShow less
[68Ga]Ga-FAPI-46 positron emission tomography for detection of lymph node metastasis in early rectal cancer (FARE Trial)
Group A: Diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of one 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.
Inclusion: Group A: Patients aged ≥18 years with suspected or confirmed cT1-3N0-1M0 rectal cancer, defined as tumour invasion not extending beyond the perirectal tissue on standard MRI, with or without evidence of locoregional LNM on MRI, and no evidence of distant metastases on chest and abdominal CT; Group A: Scheduled for primary TME (i.e. without prior local excision and without neo-adjuvant treatment); Group A: Approval of the local multidisciplinary colorectal tumour board for performing primary TME; Group B: Patients aged ≥18 years with high-risk rectal cancer, defined as the presence of at least one histological risk factors as described in the latest Dutch CRC guideline; Group B: Planned for completion TME following local excision; Group B: Approval of the local multidisciplinary colorectal tumour board for performing completion TME.
Exclusion: Group A & B: Neoadjuvant treatment (for current diagnosis of rectal cancer); Group A & B: Not able to communicate in Dutch or English; Group A & B: Pregnant (either the patient or someone in the same household) or lactating women.