18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
NCT ID: NCT04615156
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
10000 participants
INTERVENTIONAL
2020-11-01
2027-11-01
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Evaluation for adverse events from 18F-2-fluoro-2-deoxy-D-glucose produced by a new manufacturer
18F-2-fluoro-2-deoxy-D-glucose
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.
Interventions
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18F-2-fluoro-2-deoxy-D-glucose
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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)
* 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
ALL
No
Sponsors
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Eastern Health, Canada
OTHER
Responsible Party
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Dr. Jeffery Flemming
Clinical Chief, Nuclear and Molecular Medicine, Eastern Health
Central Contacts
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Other Identifiers
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231364
Identifier Type: OTHER
Identifier Source: secondary_id
231364
Identifier Type: -
Identifier Source: org_study_id