NCT04615156Not yet recruitingPhase 3
18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
Evaluation of 18F-2-fluoro-2-deoxy-D-glucose Produced by a New Manufacturer, for Safety, Through the Identification of Adverse Events, and Efficacy, Through the Evaluation of Its Ability, When Utilized in Performance of a Positron Emission Tomography Computed Tomography Scan, to Correctly Distinguish Benign From Malignant Solitary Pulmonary Nodules.
Source: ClinicalTrials.gov · Last updated 4 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 10000 (estimated)
- First submitted
- 28 Oct 2020
- Start date
- 1 Nov 2020
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Eastern Health, Canada
- Diseases
- Childhood cancers
- NCT number
- NCT04615156
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 10000
- From 1 Nov 2020 to the primary completion date, 1 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients unwilling to proceed with scan (I.e. claustrophobia) prior to injection
- If patients inability to follow staff direction causes a safety hazard prior to injection
Other
- Pregnant women: if there is any possibility of pregnancy, a blood Beta Human Chorionic Gonadotropin level will be obtained as per Eastern Health policy.
- Patients unwilling or unable to stop breast feeding for 12 hours
- Patients who are too medically unstable to tolerate the uptake period or lie flat for the duration of the scan
- Patients who exceed the safe weight limit of the Positron Emission Tomography Computed Tomography scanner bed (500 lbs.) or who cannot fit through the bore (70 cm diameter)
Who the study is looking for
- Known or suspected disease for which 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography Computed Tomography is appropriate for the investigation of. This includes, but is not limited to: Known or suspected cancer, neurological disorders (dementia or epilepsy), cardiac conditions (inflammation or myocardial viability), known or suspected presence of infection/inflammation process
- Patients must satisfy all the following:
- Able to provide written informed consent, or consent obtained from appropriate guardian
- Able to tolerate the physical and logistic requirements of completing a Positron Emission Tomography Computed Tomography scan
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.