Ga68-fapi-46

What it is and how it works

68Ga-FAPI-46 is a quinoline-based small-molecule inhibitor of fibroblast activation protein labelled with gallium-68. It binds to FAP on cancer-associated fibroblasts in tumour stroma, giving high tumour-to-background contrast on PET across many cancer types with low uptake in normal brain and liver.

Indications

Investigational PET imaging of FAP-expressing tumours (e.g. pancreatic, gastrointestinal, breast, lung, head and neck cancers and sarcomas) for staging and assessment of disease extent; used under clinical research or special-access arrangements.

Dosage and administration (summary)

Dosing is individualised according to the imaging or study protocol and administered by nuclear medicine specialists as a single intravenous injection.

Contraindications

Hypersensitivity to the active substance or excipients.

Warnings and precautions

Uptake also occurs in non-malignant fibrotic, inflammatory and healing tissues (including arthritis, fibrosis, post-operative and post-radiation changes), which can cause false-positive findings. Radiation exposure should be minimised and images interpreted with clinical correlation.

Pregnancy

Generally avoided in pregnancy because of fetal radiation exposure.

Storage and supply

Prepared on site and used within its short shelf-life (gallium-68 half-life about 68 minutes), kept in appropriate radiation shielding.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.