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

Eastern Health, Canada

Status and phase

Not yet enrolling

Phase 3

Conditions

Adverse Event

Solitary Pulmonary Nodule

Oncology

18F-2-fluoro-2-deoxy-D-glucose

Treatments

Drug: 18F-2-fluoro-2-deoxy-D-glucose

Study type

Interventional

Funder types

Other

Identifiers

NCT04615156

231364 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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