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Recruiting NCT06244979

iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

Phase II Interventional Pulmonary Aspergillosis Chronic Pulmonary Aspergillosis Allergic Bronchopulmonary Aspergillosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B).
Who it may be relevant to
Registry conditions: Pulmonary Aspergillosis, Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a single center open-label feasibility trial involving a single study visit for participants. The purpose of the study is to demonstrate the feasibility of \[68Ga\]Ga-DFO-B PET/CT (gallium-68-deferoxamine) for the visualization of pulmonary Aspergillus infection. The incidence of fungal infections is on the rise and are associated with significant mortality. Diagnosis pulmonary aspergillosis can be can be challenging, often requiring invasive tests such as bronchoscopy and lung tissue biopsies. Molecular imaging, specifically using radiolabeled siderophores like \[68Ga\]Ga-DFO-B, offers a non-invasive and location-specific approach to visualize and evaluate infections. Siderophores, critical for pathogenic microbes like Aspergillus fumigatus, play a role in iron acquisition. Preclinical studies with radiolabeled deferoxamine (DFO-B) demonstrated distinct accumulation at infection sites. Additionally, \[68Ga\]Ga-DFO-B PET/CT may differentiate between Aspergillus infection and cancer, making it a promising non-invasive diagnostic tool for pulmonary aspergillosis.

Interventions

  • Other Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B)
    100 MBq +/- 10% \[68Ga\]Ga-DFO-B which contains 100 µg DFO-B (see description in arm description)

Primary outcome measures

  • Standardized uptake values (SUV) of [68Ga]Ga-DFO-B [Time frame: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B]
  • Target-to-background ratios of [68Ga]Ga-DFO-B [Time frame: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • RadboudUMC — Nijmegen

Identifiers

NCT: NCT06244979 · 115136 · 2023-509744-10-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗