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NCT00629460 · ClinicalTrials.gov registry record
A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 27
- Enrollment target
NCT00629460 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 27 participants.
The verdict
NCT00629460 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 27 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00629460
The ClinicalTrials.gov registry entry for NCT00629460 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00629460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00629460 about?
NCT00629460 is a clinical study titled "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 of...
What is the current status of trial NCT00629460?
This trial is currently completed. The enrollment target is 27 participants. The study started on 2008-02. Estimated completion is 2012-04.
Who is sponsoring clinical trial NCT00629460?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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