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Positron emission tomography plus artificial intelligence to pRedict malignancy in incidental puLmonary nodulEs

Positron emission tomography plus artificial intelligence to pRedict malignancy in incidental puLmonary nodulEs - PRINCIPLE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033567
Enrollment
200
Registered
2025-01-13
Start date
2024-06-28
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

R91

Interventions

Group 1: If an IPN with a lesion size of =8 to 30 mm is detected during non-oncologically indicated CT examinations of the thorax (e.g. cardiac issues or lung diseases), FDG-PET/CT is performed in acc

Sponsors

DKFZ-Hector Krebsinstitut an der Universitätsmedizin Mannheim
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients with at least 1 detected lung lesion (5-30mm) in the CT thorax -No oncological disease in the last 5 years

Exclusion criteria

Exclusion criteria: -Lack of ability to be informed -Legal care -Lack of consent to the study -Pregnancy (no inclusion of pregnant women)

Design outcomes

Primary

MeasureTime frame
Detection rate and discrimination of IPN according to their malignancy risk

Secondary

MeasureTime frame
- Evaluation of the sensitivity and image quality of LAFOV FDG-PET/CT and photoncounting CT in the detection of IPN - Biopsy of IPN using preinterventional diagnostics on photoncounting CT vs. LAFOV FDG-PET/CT - Prediction of the clinical course (e.g. progression-free survival, overall survival) based on image parameters in photoncounting CT vs. LAFOV FDG-PET/CT - Correlation between FDG enrichment in LAFOV PET/CT and other clinical parameters (histological clinical parameters (histological tumour stage, laboratory parameters)

Countries

Germany

Contacts

Public ContactFreba Grawe

DKFZ-Hector Krebsinstitut an der Universitätsmedizin Mannheim

Freba.Grawe@dkfz.de06221 42-2263

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026