NCT06440616 Benefit of Spectral Information in Patients Suspected for Lung Cancer
| NCT ID | NCT06440616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital at Herlev |
| Condition | Lung Neoplasm Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-05-24 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations. As secondary aims we will compare conventional CT, CT + 18Flouro-deoxy-glucose (18F-FDG) positron emission tomography (PET) and PCCT + 18F-FDG PET for the tumor-node-metastasis (TNM) staging of lung cancer patients. PCCT with and without spectral information to assess the need for additional work-up,TNM classification, and sensitivity/specificity for malignant lesions. Patients will be randomized for reading with or without spectral information available within a clinical setting. The clinical readings are performed as a structured reports of all significant findings. Including both malignant and benign findings. Furthermore, in case additional follow-up/work-up is needed based on the guidelines on incidental findings by the American College of Radiology (ACR), this will be reported as well. If lesions suspicious of pulmonary malignancy is present, a provisional TNM classification is provided based on the scan findings. After 3 months, the patient record is reviewed where additional examinations that can be attributed to the PCCT scan are recorded. The financial impact is calculated by a health economist based on the findings. PET/CT, conventional CT and PCCT combined with PET will be assessed retrospectively for comparison. Endpoints are number of supplementary examinations and cost savings. Sensitivity and specificity for any malignant finding. The T, N and M stages are assessed separately as diagnostic measures by the McNemar's test with a reference standard from the Danish Lung cancer register. The number of malignant lesions will be determined by reviewing the patient records incl. pathology assessment if available 12 months after inclusion of the last patient.
Eligibility Criteria
Inclusion Criteria: * Patients suspected of lung cancer refered to Copenhagen University Hospital as per the guidelines from the danish national health authorities from either the general practitioner or from the department of pulmonology. * Informed consent Exclusion Criteria: * Patients who cannot tolerate intravenous iodinated contrast * Already verified lung cancer from another institution * Comorbidities that exclude the patient from receiving treatment * Lack of reference standard in the form of either histology or follow-up * Known extrapulmonary malignancy * Technical limitations within the scans/reconstructions * other Pr. the 29th of September included 433 participants.
Contact & Investigator
Michael B Andersen, PhD
PRINCIPAL INVESTIGATOR
Copenhagen University Hospital at Herlev
Frequently Asked Questions
Who can join the NCT06440616 clinical trial?
This trial is open to participants of all sexes, studying Lung Neoplasm Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06440616 currently recruiting?
Yes, NCT06440616 is actively recruiting participants. Contact the research team at michael.brun.andersen@regionh.dk for enrollment information.
Where is the NCT06440616 trial being conducted?
This trial is being conducted at Herlev, Denmark.
Who is sponsoring the NCT06440616 clinical trial?
NCT06440616 is sponsored by Copenhagen University Hospital at Herlev. The principal investigator is Michael B Andersen, PhD at Copenhagen University Hospital at Herlev. The trial plans to enroll 1,000 participants.