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Sequential diagnostics of pulmonary fungal infections

Sequential diagnostics of pulmonary fungal infections - SIGNALS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56740
Enrollment
120
Registered
2024-05-01
Start date
2024-08-07
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

invasive fungal infection pulmonary fungal infection

Interventions

One additional non contrast enhanced low dose CT thorax. Routine of care follow up or clinically triggered CT thorax will be performed following a weekly interval if feasible

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Incidence of possible or probable PFI using this diagnostic protocol 2. Rate and diversity of pathological imaging findings suggestive of PFI 3. Compare diagnostic performance of standardized conventional radiological assessment (IPARADS) versus computer aided assessment

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)