Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440616
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-27
Brief Title:
Benefit of Spectral Information in Patients Suspected for Lung Cancer
Sponsor:
Copenhagen University Hospital at Herlev
Organization:
Copenhagen University Hospital at Herlev
Study Overview
Official Title:
Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-upTNM classification and sensitivityspecificity 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-upwork-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 PETCT 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 McNemars 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
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-upTNM classification and sensitivityspecificity 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-upwork-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 PETCT 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 McNemars 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None