The MIRAGE study. Use of radioactively labelled deferoxamine for a novel purpose: imaging pulmonary aspergillosis with PET/CT scans.

Phase 1

Conditions: Pulmonary aspergillosis
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2023-509744-10-00

Lead Sponsor: Radboud universitair medisch centrum / RADBOUDUMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the feasibility of [68Ga]Ga-DFO-B PET/CT for the visualization of pulmonary Aspergillus infection.;Secondary Objective: To investigate the influence of potential confounding factors on in vivo biodistribution of [68Ga]Ga-DFO-B;Primary end point(s): Quantitative uptake and target-to-background ratios of [68Ga]Ga-DFO-B in suspected aspergillus lesions in patients with pulmonary aspergillosis.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):[68Ga]Ga-DFO-B uptake patterns in the different forms of pulmonary aspergillosis.;Secondary end point(s):[68Ga]Ga-DFO-B uptake patterns in patients with and without co-infections.;Secondary end point(s):[68Ga]Ga-DFO-B uptake patterns compared to the human iron status including serum iron, transferrin, transferrin saturation, and ferritin.;Secondary end point(s):Cell-bound and free fraction of [68Ga]Ga-DFO-B.;Secondary end point(s):[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.