Clinical Trials Logo

Clinical Trial Summary

Because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard method of excluding pulmonary metastases. However, CT lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. We found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on CT imaging features was limited (57% to 67% rate of correct classification). Also, there was only slight to moderate agreement in nodule classification between these reviewers.

Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the last five years, 44% (22/50) had only benign nodules.

Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG) positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives information about the metabolic activity of the nodule. Nodules that are malignant have more metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has been little work done in children to determine the value of PET or PET-CT in the evaluation of pulmonary nodules.


Clinical Trial Description

In this study, we seek to assess the feasibility of performing PET-CT for the evaluation of pulmonary nodules in children to obtain preliminary data for sample size determination for a larger multi-institutional trial. The primary objective of the multi-institutional trial will be to compare the accuracy of diagnostic CT alone to PET-CT in distinguishing benign from malignant nodules in children with solid malignancies. We are hopeful that PET-CT will allow us to better direct the clinical management of these patients and to reduce the number of invasive procedures performed to confirm the presence of benign disease. ;


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT00629460
Study type Observational
Source St. Jude Children's Research Hospital
Contact
Status Completed
Phase N/A
Start date February 2008
Completion date April 2012

See also
  Status Clinical Trial Phase
Recruiting NCT06056999 - New Method to Differentiate Benign and Malignant Pulmonary Nodules.
Recruiting NCT04182893 - Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules
Active, not recruiting NCT03651986 - Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
Not yet recruiting NCT05067023 - Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging N/A
Completed NCT02146131 - Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 ) N/A
Recruiting NCT04462185 - A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
Recruiting NCT04690790 - Pulmonary Nodule Localization Prospective Validation
Recruiting NCT05525260 - Limonene for Pulmonary Nodule Chemoprevention Phase 2
Completed NCT03420885 - Effects of Ba Duan Jin for Patients With Pulmonary Nodules N/A
Active, not recruiting NCT05091437 - DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis