Benefit of Spectral Information in Patients Suspected for Lung Cancer

Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasm Malignant
• Intervention / Treatment: Device: Spectral CT images generated by a photon counting CT scanner

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael B Andersen, PhD; Phone Number: +45 38 68 38 68; Email: michael.brun.andersen@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Recruiting
      • Copenhagen University Hospital Herlev
      • Contact: Michael B Andersen, PhD; Phone Number: +45 38 68 38 68; Email: michael.brun.andersen@region.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CT images without spectral information available; Reported without access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings.
Experimental: CT images with spectral information available; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
T, N, and M stage	Determine the accuracy of T, N, and M stage based on PCCT, conventional CT, PET/CT and PET/PCCT. Retrospective assessment 24 months after primary scan.	24 months
Number of malignant lesions	Determine the number of found malignant lesions in each arm. Reference standard will be follow up or pathology within a minimum of one year of the scan. That means 12 months after the end of the inclusion period.	24 months

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Collaborators: Aarhus University Hospital; Rigshospitalet, Denmark
• Investigators: Principal Investigator: Michael B Andersen, PhD, Copenhagen University Hospital at Herlev

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Computed tomography; Spectral CT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: H- 23045674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No