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BEFAST STUDY: [68Ga]Ga-FAPI total body PET/CT for Better and Faster imaging in cancer Protocol: [68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503632-41-01
Enrollment
90
Registered
2023-11-01
Start date
2024-01-30
Completion date
Unknown
Last updated
2025-12-10

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

Conditions

Pancreatic cancer and gastroesophageal cancer (esophagus, gastroesophageal junction (GEJ) and gastric cancer)

Brief summary

1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).

Detailed description

1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT after 60 min, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV), 2) Estimated potential impact/change in patient management., 3) Description of FAPI-uptake from lesions suspicious of malignancy.

Interventions

DRUGinjektionsvæske
DRUGopløsning
DRUG68GA-FAPI-46

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).

Secondary

MeasureTime frame
1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT after 60 min, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV), 2) Estimated potential impact/change in patient management., 3) Description of FAPI-uptake from lesions suspicious of malignancy.

Countries

Denmark

Outcome results

None listed

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