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

November 2, 2020 updated by: Dr. Jeffery Flemming, Eastern Health, Canada

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation for adverse events from 18F-2-fluoro-2-deoxy-D-glucose produced by a new manufacturer
Drug: 18F-2-fluoro-2-deoxy-D-glucose
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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
For the length of time required to perform informed consent, the scan, and follow-up interview for adverse events, approximately 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Health, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2027

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231364 (Other Identifier: Protocol number assigned by Health Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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