2023-506594-35-00RecruitingPhase 4
FARE Trial
[68Ga]Ga-FAPI-46 positron emission tomography for detection of lymph node metastasis in early rectal cancer (FARE Trial)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 27 Jul 2023
- Start date
- 24 Mar 2025
- Lead sponsor
- Amsterdam UMC
- Diseases
- Colorectal cancer
- EU CT number
- 2023-506594-35-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Group A & B: Neoadjuvant treatment (for current diagnosis of rectal cancer)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.