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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Radboud universitair medisch centrum Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

1 Apr 2025 → ongoing

Decision date (initial)

2024-04-18

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Radboudumc

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To demonstrate the feasibility of [68Ga]Ga-DFO-B PET/CT for the visualization of pulmonary Aspergillus infection.

Secondary objectives 1

1. To investigate the influence of potential confounding factors on in vivo biodistribution of [68Ga]Ga-DFO-B

Conditions and MedDRA coding

Pulmonary aspergillosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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

Exclusion criteria 5

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Quantitative uptake and target-to-background ratios of [68Ga]Ga-DFO-B in suspected aspergillus lesions in patients with pulmonary aspergillosis.

Secondary endpoints 5

1. [68Ga]Ga-DFO-B uptake patterns in the different forms of pulmonary aspergillosis.
2. [68Ga]Ga-DFO-B uptake patterns in patients with and without co-infections.
3. [68Ga]Ga-DFO-B uptake patterns compared to the human iron status including serum iron, transferrin, transferrin saturation, and ferritin.
4. Cell-bound and free fraction of [68Ga]Ga-DFO-B.
5. [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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud universitair medisch centrum Stichting

Sponsor organisation

Radboud universitair medisch centrum Stichting

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Radboud universitair medisch centrum / RADBOUDUMC

Contact name

Laura Michon

Public contact point

Organisation

Radboud universitair medisch centrum / RADBOUDUMC

Contact name

Laura Michon

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications