Clinical trial • Not applicable • Other

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

Not applicable trial of [AL[18F]F]FAPI-74 for Progressive pulmonary fibrosis | Pulmonary fibrosis. 20 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Progressive pulmonary fibrosis | Pulmonary fibrosis
Trial Stage
Not applicable
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
10-11-2023
First CTIS Authorization Date
01-03-2024

Trial design

Not applicable trial in Netherlands.

Target Sample Size
20

Eligibility

Recruits 20 Vulnerable population not selected. Exclusion criterion: 'Incapacity to give informed consent personally' — participants must be able to give informed consent personally. No assent procedures or paediatric consent described..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Vulnerable population not selected. Exclusion criterion: 'Incapacity to give informed consent personally' — participants must be able to give informed consent personally. No assent procedures or paediatric consent described.

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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- FAPI activity concentration in patients with predominant active fibrosis and predominant inflammation","definition_or_measurement_approach":"FAPI activity concentration as assessed by FAPI-PET/CT imaging"}

Secondary endpoints

  • {"endpoint_text":"- Activity thresholds for positive FAPI-PET/CT confirming active fibrosis,","definition_or_measurement_approach":"Determination of activity thresholds using FAPI-PET/CT imaging"}
  • {"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 (FAPI-PET/CT), HRCT measures of ILD/reticulation and serum biomarkers for inflammation"}

Recruitment

Planned Sample Size
20
Recruitment Window Months
12
Consent Approach
Participants must give informed consent personally; exclusion criterion 'Incapacity to give informed consent personally'. No assent or paediatric consent procedures described. No languages for consent specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Netherlands

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
01-03-2024
Processing Time Days
8
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
St Antonius Hospital
Department Name
Department of Nuclear Medicine
Contact Person Name
Andor van den Hoven
Number Of Participants
20

Sponsor

Primary sponsor

Full Name
St Antonius Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
[18F]-AlF-FAPI-74
Active Substance
[AL[18F]F]FAPI-74
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS

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