Sequential diagnostics of pulmonary fungal infections

Recruiting

• Conditions: invasive fungal infection; pulmonary fungal infection; 10018849; 10017528; 10027655

• Registration Number: NL-OMON56740
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

• Age 18 yrs and older • Inclusion within 1 day before start of cytoreductive
treatment or remission induction chemotherapy for acute myeloid leukemia (AML)
or myelodysplastic syndrome (MDS) OR for myeloablative conditioning of
allogeneic stem cell transplantation (HSCT) including FLAMSA conditioning •
Expected absolute neutrophil count of <0.5 x109 for at least 10 days • No
previous or current history of proven or probable IMD • No current diagnosis of
pneumonia • No current respiratory distress or ventilation support ( low flow
oxygen is permitted ie by nasal canula) • Patients must be able to be
transferred to the radiology department for scanning • Female subjects with
childbearing potential must have a negative serum (or urine) pregnancy test
within 3 days prior to inclusion • Absence of any psychological, familial ,
sociological condition potentially hampering compliance with the study protocol
and follow up; those conditions should be discussed with the patient before
registration in the trial • Before registration patients should give written
informed consent according to ICH/GCP regulations

Exclusion Criteria

• Pregnant female subjects
• Current or previous history of primary or metastatic lung malignancy
• Treatment for pulmonary fungal infection in preceding 3 months
• Inflammatory bowel disease or any inflammatory bowel condition

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Incidence of possible or probable PFI using this diagnostic protocol<br /><br>2. Rate and diversity of pathological imaging findings suggestive of PFI<br /><br>3. Compare diagnostic performance of standardized conventional radiological<br /><br>assessment (IPARADS) versus computer aided assessment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(a) Describe imaging features that are not associated with PFI: number of<br /><br>lesions/events<br /><br>(b) Describe the development and reduction of PFI features during aplasia and<br /><br>neutropenia recovery.<br /><br>(c) Exploration of the imaging kinetics and response kinetics during fungal<br /><br>infections with computer aided analysis of target lesions<br /><br>(d) Describe treatment duration and outcome following CT-guided response<br /><br>evaluation</p><br>