Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275477
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-01-29
Brief Title:
68Gallium-FAPI PETCT Imaging in Chronic Inflammatory and Fibrotic Diseases
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
68Gallium-FAPI PETCT Imaging in Chronic Inflammatory and Fibrotic Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARADISE
Brief Summary:
This single-center pilot study is designed to explore the preliminary utility of the 68Ga Ga-FAPI imaging agent in positron emission tomography PET combined with computed tomography CT for a range of chronic inflammatory and fibrosing diseases The study focuses on the potential of 68Ga Ga-FAPI a novel radiotracer targeting Fibroblast Activation Protein FAP to improve diagnostic accuracy in various medical conditions Thirteen distinct clinical situations have been selected for this investigation including rheumatoid arthritis liver fibrosis and systemic lupus among others This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases
Detailed Description:
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 andor 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 Sjögrens syndrome
Systemic scleroderma
Systemic lupus
Inflammatory myopathies
Primary or secondary myelofibrosis
Other orphan systemic diseases
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 andor 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 Sjögrens syndrome
Systemic scleroderma
Systemic lupus
Inflammatory myopathies
Primary or secondary myelofibrosis
Other orphan systemic diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None