[AL[18F]F]FAPI-74 for Progressive pulmonary fibrosis | Pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- ≥ 18 years of age"}
• {"criterion_text":"- New diagnosis of PPF"}
• {"criterion_text":"- A minimum of 20% of lung parenchyma is aberrant (fibrosis, inflammation or both)"}
• {"criterion_text":"- MDT indication for treatment with either immunosuppressive drugs or antifibrotic drug"}

Exclusion criteria

• {"criterion_text":"- Prior or current treatment with antifibrotic drugs"}
• {"criterion_text":"- Active malignancy"}
• {"criterion_text":"- Inability to undergo a PET/CT at the Sint Antonius Hospital"}
• {"criterion_text":"- Incapacity to give informed consent personally"}
• {"criterion_text":"- Pregnancy"}

Primary endpoints

• {"endpoint_text":"- FAPI activity concentration in patients with predominant active fibrosis and predominant inflammation","definition_or_measurement_approach":"Measured as FAPI activity concentration on PET/CT imaging (FAPI-PET/CT)."}

Secondary endpoints

• {"endpoint_text":"- Activity thresholds for positive FAPI-PET/CT confirming active fibrosis,","definition_or_measurement_approach":"Determination of activity thresholds on FAPI-PET/CT that define positive imaging for active fibrosis."}
• {"endpoint_text":"- Correlation between baseline FAPI activity and ILD extent/degree of reticulation on HRCT as well as serum biomarkers for inflammation","definition_or_measurement_approach":"Correlation analysis between baseline FAPI activity on PET/CT and ILD extent/degree of reticulation on HRCT and serum biomarkers for inflammation."}

Netherlands

Earliest CTIS Part Ii Submission Date

19-09-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

1

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

St Antonius Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Antonius Research Fund (Antonius Onderzoeksfonds)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"ERASMUS MC","duties_or_roles":"Named in product information for the investigational product","organisation_type":""}