Benefit of Spectral Information in Patients Suspected for Lung Cancer

NCT06440616 | Recruiting

• 1 other identifier: H- 23045674
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm Malignant

Keywords

Computed tomography; Spectral CT

Outcome Measures

Primary Outcomes (1)

• Number of follow up examinations

  Determine the number of suggested follow-up examinations based on the initial CT scan to learn the significance of spectral information in a clinical setting.

  Baseline

Secondary Outcomes (2)

• T, N, and M stage

  24 months

• Number of malignant lesions

  24 months

Study Arms (2)

CT images without spectral information available

NO INTERVENTION

Reported without access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings.

CT images with spectral information available

EXPERIMENTAL

Reported with access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings.

Device: Spectral CT images generated by a photon counting CT scanner

Interventions

Spectral CT images generated by a photon counting CT scanner DEVICE

The reading radiologist will in the experimental arm have access to spectral CT images in the form of low virtual monoenergetic images, virtual non-contrast images, iodine maps and effective atomic number. In the non-interventional arms the reading radiologist will only have access to conventional CT images.

CT images with spectral information available

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: collaborator
• Aarhus University Hospital: collaborator
• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Copenhagen University Hospital Herlev

Herlev, Capital Region, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael B Andersen, PhD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael B Andersen, PhD

CONTACT

38 68 38 68; michael.brun.andersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 4, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)