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

NCT00629460 | Completed

• 1 other identifier: PETPUL
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Nodules

Keywords

Pulmonary Nodules

Outcome Measures

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.

  2 years

Study Arms (1)

1

there is only one group/cohort. This is a non-therapeutic study.

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients with known or suspected malignant solid tumors found by CT to have at least one pulmonary nodule measuring\> or equal to 0.5 cm and \< or equal to 3.0 cm in size will be eligible for enrollment.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

Mary E. McCarville

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mary E McCarville, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 6, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2012
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

US (1)