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Trial Title:
Benefit of Spectral Information in Patients Suspected for Lung Cancer
NCT ID:
NCT06440616
Condition:
Lung Neoplasm Malignant
Conditions: Official terms:
Lung Neoplasms
Neoplasms
Conditions: Keywords:
Computed tomography
Spectral CT
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Spectral CT images generated by a photon counting CT scanner
Description:
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.
Arm group label:
CT images with spectral information available
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Copenhagen University Hospital Herlev
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Michael B Andersen, PhD
Phone:
38 68 38 68
Phone ext:
+45
Email:
michael.brun.andersen@region.dk
Start date:
May 24, 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Copenhagen University Hospital at Herlev
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Source:
Copenhagen University Hospital at Herlev
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06440616
