AMPHOTERICIN B for Chronic pulmonary aspergillosis

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- The patient is breastfeeding, or of childbearing potential and is pregnant, planning to become pregnant within 3 months of the SPECT imaging, unable to provide a negative pregnancy test at screening, or unwilling to use effective contraception during the study and for at least 3 months after the last SPECT scan."}
• {"criterion_text":"- The patient is not able to lie supine in the scanner."}
• {"criterion_text":"- The patient has previously reported intolerance to inhalation medication."}
• {"criterion_text":"- The patient is unable to provide informed consent due to lack of decision-making capacity"}

Primary endpoints

• {"endpoint_text":"- The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).","definition_or_measurement_approach":"Measured through single-photon emission computed tomography (SPECT/CT) to quantify pulmonary deposition of AmBisome."}
• {"endpoint_text":"- The amount of AmBisome in the lungs compared to the blood concentrations to understand drug absorption and distribution","definition_or_measurement_approach":"Comparison of pulmonary deposition (SPECT/CT) with measured blood concentrations to assess absorption and distribution."}
• {"endpoint_text":"- The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics.","definition_or_measurement_approach":"Determination based on measured pulmonary deposition (SPECT/CT) and pharmacokinetic analyses."}

Secondary endpoints

• {"endpoint_text":"- A validated GMP-grade procedure for Technetium-99m labelled AmBisome.","definition_or_measurement_approach":"Development, preparation and validation of a GMP-grade procedure for technetium-99m labelling of AmBisome."}
• {"endpoint_text":"- Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs.","definition_or_measurement_approach":"Collection and counting of adverse reactions and (S)AEs, including monitoring respiratory symptoms and pulmonary function."}
• {"endpoint_text":"- Assessment of PROs using a validated PRO instruments (TSQM) to assess side effects, treatment convenience and global satisfaction with therapy.","definition_or_measurement_approach":"Assessment of patient-reported outcomes using TSQM to evaluate side effects, convenience and overall satisfaction."}

Netherlands

Earliest CTIS Part Ii Submission Date

29-08-2025

Latest Decision Or Authorization Date

04-09-2025

Processing Time Days

6

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands