Back to results18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
Primary Purpose
Solitary Pulmonary Nodule, Oncology, 18F-2-fluoro-2-deoxy-D-glucose
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
18F-2-fluoro-2-deoxy-D-glucose
Sponsored by
About this trial
This is an interventional diagnostic trial for Solitary Pulmonary Nodule focused on measuring 18F-2-fluoro-2-deoxy-D-glucose, Adverse Event, Solitary Pulmonary Nodule, Oncology
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation for adverse events from 18F-2-fluoro-2-deoxy-D-glucose produced by a new manufacturer
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04615156
First Posted
October 28, 2020
Last Updated
November 2, 2020
Sponsor
Eastern Health, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04615156
Brief Title
18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
November 1, 2027 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Health, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Oncology, 18F-2-fluoro-2-deoxy-D-glucose, Adverse Event
Keywords
18F-2-fluoro-2-deoxy-D-glucose, Adverse Event, Solitary Pulmonary Nodule, Oncology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evaluation for adverse events from 18F-2-fluoro-2-deoxy-D-glucose produced by a new manufacturer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18F-2-fluoro-2-deoxy-D-glucose
Intervention Description
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Morgan, MNRN
Phone
709-777-1133
Email
andrea.morgan@easternhealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffery Flemming, MD
Phone
709-777-1133
Email
jeffery.flemming@easternhealth.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography
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