A Phase 3 interventional study of 18F-2-fluoro-2-deoxy-D-glucose in Solitary Pulmonary Nodule, Oncology and 18F-2-fluoro-2-deoxy-D-glucose, sponsored by Eastern Health, Canada. Not yet recruiting. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Eastern Health, Canada · Phase 3, Interventional, and Diagnostic
The study objectives are as follows:
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.
188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →This is the only study on the registry with Eastern Health, Canada as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients must satisfy all the following:
Exclusion Criteria:
Drug: 18F-2-fluoro-2-deoxy-D-glucose
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.
Measuring the safety of 18F-2-fluoro-2-deoxy-D-glucose produced by a new manufacturer by evaluating for any adverse events that occur during their Positron Emission Tomography Computed Tomography scan appointment.
Evaluation for any adverse events after administration of 18F-2-fluoro-2-deoxy-D-glucose produced by Eastern Health in the Nuclear and Molecular Medicine Department who is a new manufacturer
Time frame: For the length of time required to perform informed consent, the scan, and follow-up interview for adverse events, approximately 4 hours
Evaluation of the sensitivity, specificity and accuracy of 18F-2-fluoro-2-deoxy-D-glucose in the assessment of solitary pulmonary nodules compared to anatomic pathology, or more than 6 month follow-up stability when not available.
Assess the sensitivity, specificity and accuracy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography Computed Tomography in differentiating benign from malignant solitary pulmonary nodules. This is being done with a view towards eventually applying for an Abbreviated New Drug Submission.
Time frame: Variable, from the time of the scan to appropriate follow-up (either biopsy or follow-up imaging that occurs more than 6 months after the Positron Emission Tomography Computed Tomography study)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.