BridgeMD
FARE Trial
EU CTIS ID: 2023-506594-35-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Group A & B: Not able to communicate in Dutch or English
- Group A & B: Neoadjuvant treatment (for current diagnosis of rectal cancer)
- Group A & B: Pregnant (either the patient or someone in the same household) or lactating women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.