Benefit of Spectral Information in Patients Suspected for Lung Cancer

Lung Neoplasm Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440616
• Other study ID #: H- 23045674
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: Copenhagen University Hospital at Herlev
• Contact: Michael B Andersen, PhD
• Phone: 38 68 38 68
• Email: michael.brun.andersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm Malignant
• Lung Neoplasms
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Herlev	Herlev	Capital Region

Sponsors (3)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Aarhus University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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