A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors
|ClinicalTrials.gov Identifier: NCT00629460|
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : October 17, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors|
|Study Start Date :||February 2008|
|Primary Completion Date :||August 2010|
|Study Completion Date :||April 2012|
there is only one group/cohort. This is a non-therapeutic study.
- To assess the feasibility of performing PET-CT for the evaluation of pulmonary nodules in children with solid malignancies and to obtain preliminary data for sample size determination for a larger, multi-institutional prospective study. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629460
|United States, Tennessee|
|Mary E. McCarville|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Mary E McCarville, MD||St. Jude Children's Research Hospital|