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18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The study objectives are as follows: * To determine the safety of trial 18F-2-fluoro-2-deoxy-D-glucose, produced by a new manufacturer, by surveillance for adverse events in patients having Positron Emission Tomography Computed Tomography scans in a comprehensive program for indications including, but not limited to, oncology, neurology, cardiac and infectious/inflammatory processes. * To determine the efficacy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography in differentiating benign from malignant solitary pulmonary nodules and calculate sensitivity, specificity, and accuracy using pathologic confirmation as the gold standard when available, or greater than 6 month follow up stability on Computed Tomography scan when not. The purpose of performing this clinical trial is to provide local access of 18F-2-fluoro-2-deoxy-D-glucose to the patients of Newfoundland and Labrador. This product has been offered to patients over the last three years by transporting from facilities outside of the province. There have been significant delays in access and in fact, times where 18F-2-fluoro-2-deoxy-D-glucose has not been available through this process. This has caused delays and limitations of treatments for patients who rely on Positron Emission Tomography Computed Tomography scans for diagnosis.
Trial Details
NCT Number NCT04615156
Lead Sponsor Eastern Health, Canada
Conditions
(from sponsor)
Solitary Pulmonary Nodule, Oncology, 18F-2-fluoro-2-deoxy-D-glucose, Adverse Event
Related terms Neoplasms, Solitary Pulmonary Nodule
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov