Clinical Trials Logo

Clinical Trial Summary

To assess the variability of semi-automated volume measurements of pulmonary nodules on same-day repeated scans of equal radiation dose from two different CT scanners: One high-end CT scanner with standard spatial resolution (CT1) and one UHRCT scanner (CT2), in patients with known or suspected pulmonary metastases.


Clinical Trial Description

Rationale: Ultra-high resolution computed tomography (UHRCT) produces radiological images with a spatial resolution of 0.25 mm in a matrix of 1024x1024. This should decrease measurement variation of nodule growth as a marker of malignancy, by making nodule delineation more precise for automatic volumetry segmentation and volume doubling time assessment than in conventional CT. If possible, this can shorten follow up of incidental pulmonary nodules to exclude malignancy, with less medicalisation and patient anxiety.

Objective: To assess the variability of semi-automated volume measurements of pulmonary nodules in patients with known or suspected pulmonary metastases on same-day repeated scans of equal radiation dose from two different CT scanners: CT scanner with standard spatial resolution (conventional CT, CT1) and UHRCT (CT2).

Study design: This is a single center prospective trial on 80 patients with known or suspected pulmonary metastases who are scheduled for chest and/or abdominal CT. Study participants will undergo two additional partial chest CT scans on either CT 1 or CT 2 for research purpose only, at similar radiation dose. Patients are equally divided across CT 1 and 2.

Study population: Patients who are 18 years or older with known solid pulmonary nodules compatible with metastases and who are willing and able to give informed consent are eligible. Patients are excluded if they have less than two eligible pulmonary nodules with a z range of 16 cm. Nodules with calcifications, surrounding opacities, or vessel- or pleural abutment will be excluded from analysis.

Main study parameters/endpoints: The main endpoint of this study is the upper limit of the 95% confidence interval of repeated semi-automated nodule volume measurements of both CT scanners.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

CT imaging is associated with risks related to the use of ionizing radiation. The CT protocol including the scheduled CT scan and the additional scans in this study has been carefully designed to have a total radiation dose at the same level as the achievable diagnostic reference level of chest CT in the Netherlands, which is 542 mGycm in 2013 (1). The burden associated with the two extra study CT acquisitions comprises a dose length product (DLP) of 120.4 mGy•cm for research (1.7 mSv, which is lower than the background radiation of one year in the Netherlands, with a conversion factor of 0.014 from Deak et al (2)). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04209972
Study type Interventional
Source Radboud University
Contact
Status Completed
Phase N/A
Start date March 11, 2019
Completion date July 30, 2019

See also
  Status Clinical Trial Phase
Completed NCT03649906 - A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique N/A
Completed NCT05963945 - Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Completed NCT04066699 - Percutaneous Localization: Open-label Registry of Thoracic Surgery
Not yet recruiting NCT05477251 - Comparative Study on the Efficacy and Safety of Microwave Ablation and Lobectomy in the Treatment of Ground Glass Nodules Located in the Pulmonary Hilar Region N/A
Completed NCT03591445 - Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005) N/A
Withdrawn NCT04894682 - Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
Recruiting NCT03790735 - The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules
Active, not recruiting NCT03992183 - Utility of CAML as Diagnostic for Early Stage Lung Cancer
Recruiting NCT04552054 - Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules N/A
Recruiting NCT05389774 - DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
Recruiting NCT06308120 - A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB N/A
Completed NCT03181490 - Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
Recruiting NCT05445635 - Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses N/A
Recruiting NCT04270799 - Lung Nodule Imaging Biobank for Radiomics and AI Research
Recruiting NCT00841750 - Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection Phase 3
Recruiting NCT06426628 - Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
Recruiting NCT05415670 - Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Recruiting NCT04005677 - The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
Recruiting NCT05968898 - Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES N/A
Completed NCT04302350 - Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial N/A