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

Pulmonary Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629460
• Other study ID #: PETPUL
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: October 16, 2012
• Start date: February 2008
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Neoplasms
• Pulmonary Nodules

Locations

Country	Name	City	State
United States	Mary E. McCarville	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	Yes

External Links

•   St. Jude Children's Research Hospital