DEFEROXAMINE MESILATE for Pulmonary aspergillosis|Allergic bronchopulmonary aspergillosis (ABPA)

Inclusion criteria

• {"criterion_text":"- The patient is at least 18 years old on the day of inclusion."}
• {"criterion_text":"- The patient has suspected chronic pulmonary aspergillosis or ABPA."}
• {"criterion_text":"- There is no significant interference with standard care and follow-up."}

Exclusion criteria

• {"criterion_text":"- The patient is pregnant or planning on becoming pregnant."}
• {"criterion_text":"- The patient has severe kidney dysfunction with eGFR < 30 ml/min/kg and/or receives dialysis."}
• {"criterion_text":"- The patient has (chronic) iron overload."}
• {"criterion_text":"- The patient has been receiving antifungal treatment for more than 48 hours prior to the study day."}
• {"criterion_text":"- The patient is not able to lie still in the scanner."}

Primary endpoints

• {"endpoint_text":"- Quantitative uptake and target-to-background ratios of [68Ga]Ga-DFO-B in suspected aspergillus lesions in patients with pulmonary aspergillosis.","definition_or_measurement_approach":"Measured by [68Ga]Ga-DFO-B PET/CT imaging; quantification of tracer uptake and calculation of target-to-background ratios in suspected Aspergillus lesions."}

Secondary endpoints

• {"endpoint_text":"- [68Ga]Ga-DFO-B uptake patterns in the different forms of pulmonary aspergillosis.","definition_or_measurement_approach":"Assessed by [68Ga]Ga-DFO-B PET/CT imaging patterns across disease forms."}
• {"endpoint_text":"- [68Ga]Ga-DFO-B uptake patterns in patients with and without co-infections.","definition_or_measurement_approach":"Comparative PET/CT assessment of uptake patterns in patients stratified by presence/absence of co-infections."}
• {"endpoint_text":"- [68Ga]Ga-DFO-B uptake patterns compared to the human iron status including serum iron, transferrin, transferrin saturation, and ferritin.","definition_or_measurement_approach":"Correlation of PET/CT uptake measurements with laboratory assays for serum iron, transferrin, transferrin saturation, and ferritin."}
• {"endpoint_text":"- Cell-bound and free fraction of [68Ga]Ga-DFO-B.","definition_or_measurement_approach":"Measurement of cell-bound versus free tracer fraction (details not specified beyond endpoint statement)."}
• {"endpoint_text":"- [68Ga]Ga-DFO-B uptake patterns and cell-bound and free fraction of [68Ga]Ga-DFO-B compared to the number of neutrophils, eosinophils, monocytes, and lymphocytes.","definition_or_measurement_approach":"Comparison of PET/CT uptake and tracer fraction metrics with complete blood count differentials (neutrophils, eosinophils, monocytes, lymphocytes)."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-03-2024

Latest Decision Or Authorization Date

18-04-2024

Processing Time Days

34

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands