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

Oncology Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04615156
• Other study ID #: 231364
• Secondary ID: 231364
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 1, 2020
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2020
• Source: Eastern Health, Canada
• Contact: Andrea Morgan, MNRN
• Phone: 709-777-1133
• Email: andrea.morgan[@]easternhealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• 18F-2-fluoro-2-deoxy-D-glucose
• Adverse Event
• Multiple Pulmonary Nodules
• Neoplasms
• Oncology
• Solitary Pulmonary Nodule

Intervention

Drug:
• 18F-2-fluoro-2-deoxy-D-glucose
Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Health, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	For the length of time required to perform informed consent, the scan, and follow-up interview for adverse events, approximately 4 hours
Secondary	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.	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)