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Completed

NCT Number: NCT00629460

A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors

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.

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mary E. McCarville

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has a known or clinically suspected solid malignancy (excluding brain tumor)
  • Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy

Exclusion criteria

  • Participant has not been off therapy for at least 3 weeks before undergoing PET-CT

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Mar 6, 2008
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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