Actively Recruiting
Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer
Led by Copenhagen University Hospital at Herlev · Updated on 2026-03-20
1000
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
C
Copenhagen University Hospital at Herlev
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of photon counting CT (PCCT) and its spectral information to understand its impact on follow-up exams in patients suspected of having lung cancer. The study also compares conventional CT, CT combined with 18F-FDG PET, and PCCT combined with 18F-FDG PET for staging lung cancer based on tumor-node-metastasis (TNM) classification. The goal is to assess diagnostic sensitivity and specificity for malignant lesions and determine if spectral information improves clinical readings and reduces unnecessary follow-ups. Participants are randomly assigned to two groups: one where radiologists review CT images without spectral information and another with access to spectral CT images including low virtual monoenergetic images, virtual non-contrast images, iodine maps, and effective atomic number. Both groups follow the American College of Radiology guidelines for incidental findings and suggest follow-up exams accordingly. Additional examinations and their financial impacts are recorded three months after the PCCT scan. Retrospective assessments compare PET/CT, conventional CT, and PCCT combined with PET to evaluate diagnostic accuracy. During the study, patients undergo CT scans with or without spectral data, and radiologists create structured reports noting all significant findings, both malignant and benign. Follow-up needs are recorded, and patient records are reviewed after three months and again at 12 months to assess malignant lesion outcomes and TNM staging accuracy. The study measures the number of additional examinations required and evaluates cost savings and diagnostic performance over time. Patient involvement includes imaging, clinical evaluation, and record review for up to two years after enrollment of the last patient.
CONDITIONS
Brief Title
Benefit of Spectral Information in Patients Suspected for Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suspected of lung cancer referred to Copenhagen University Hospital as per Danish national health authority guidelines from a general practitioner or pulmonology department
- Able and willing to provide informed consent
You will not qualify if you...
- Unable to tolerate intravenous iodinated contrast
- Already confirmed lung cancer from another institution
- Comorbidities preventing treatment
- Lack of reference standard such as histology or follow-up
- Known extrapulmonary malignancy
- Technical limitations in scans or image reconstructions
- Other unspecified exclusions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At baseline
Participants undergo CT imaging with or without spectral information to assess lung cancer suspicion.
1 visit (in-person)
Duration - 24 months
Participants are followed for up to 24 months to monitor cancer staging and lesion development.
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital Herlev
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
Research Team
M
Michael B Andersen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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