Actively Recruiting

Phase Not Applicable
All Genders
ID06440616

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At baseline

Participants undergo CT imaging with or without spectral information to assess lung cancer suspicion.

1 visit (in-person)

Long-term Monitoring

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

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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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