[68Ga] Ga-FAPI is an innovative radiotracer in positron emission tomography (PET) coupled
to scanner (CT: computed tomography). It targets the membrane glycoprotein FAP
(Fibroblast Activation Protein), a specific surface marker of activated fibroblasts,
these constituting one of the main populations of the tumor microenvironment. This
radiotracer is the subject of a major development program in the field of oncology and
hematologic malignancies. In many cancers, preliminary data suggest, in terms of
diagnostic performance, the superiority of [68Ga] Ga-FAPI over the reference evaluation
modality carried out with [18F] F-FDG. These results make it possible to consider, in the
medium term, the integration of this imaging modality into routine care, for the initial
evaluation and monitoring of certain tumor pathologies.
If oncology and hematology constitute the most obvious areas of application of [68Ga]
Ga-FAPI, other areas of potential use were quickly mentioned, due to the involvement of
activated fibroblasts in the processes. remodeling of the extracellular matrix and tissue
repair in general, beyond tumor pathologies. Non-exhaustively, the potential interest of
the radiotracer is thus suggested in the characterization of benign tumor pathologies, in
the evaluation of ischemic tissues, in chronic inflammatory diseases and in fibrosing
diseases. Numerous preliminary data show that it is relevant to develop knowledge
concerning the contribution of [68Ga] Ga-FAPI to the evaluation of numerous benign
pathologies.
It is in this general context that this single-center pilot study project falls, the
general objective of which is to determine the preliminary interest of this imaging
modality in different chronic inflammatory and/or fibrosing diseases. The pathologies
included in this project were selected by taking into account the concomitant presence of
unmet medical needs in terms of disease assessment and recognized local clinical research
expertise in the area concerned. On these bases, 13 distinct clinical situations were
selected, intended to enable the production of pilot data. This approach will be able to
determine the interest in continuing clinical development in each area and will help to
specify the modalities.
The 13 clinical situations selected for this pilot study are:
Rheumatoid arthritis
Spondyloarthritis
Inflammatory enterocolopathies
Liver fibrosis
Fibrosing interstitial lung disease
Systemic sarcoidosis
Polymyalgia rheumatica and giant cell arteritis
Primary Sjögren's syndrome
Systemic scleroderma
Systemic lupus
Inflammatory myopathies
Primary or secondary myelofibrosis
Other orphan systemic diseases