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Multicenter validation trial of [18F]AlF-FAPI-74 for PET imaging of cancer-associated fibroblasts through fibroblast activation protein inhibitors (FAPI) in different tumor types.

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512059-19-00
Acronym
S67792
Enrollment
109
Registered
2024-12-18
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverse oncological patients with a clinically challenging situation., Oesophagogastric adenocarcinoma (OGA), Pancreatic ductal adenocarcinoma (PDAC)

Brief summary

OGA: detection ratio for lymph node and distant metastases (combined)., PDAC: detection ratio for lymph node and distant metastases (combined)., Clinically Challenging Situation: fraction of patients were scan was deemed contributory. This means: 1. [18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2. [18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3. [18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4. Other implications that are deemed contributory by the treating physician.

Detailed description

See trial synopsis

Interventions

DRUGTelebrix Gastro
DRUG300 mg I/ml
DRUGoplossing voor orale of rectale toediening

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OGA: detection ratio for lymph node and distant metastases (combined)., PDAC: detection ratio for lymph node and distant metastases (combined)., Clinically Challenging Situation: fraction of patients were scan was deemed contributory. This means: 1. [18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2. [18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3. [18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4. Other implications that are deemed contributory by the treating physician.

Secondary

MeasureTime frame
See trial synopsis

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026