Clinical trial NCT01136720: Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia
Official title: Clinical Trial to Evaluate the Safety and Clinical Utility of18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 18FDG
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 9463
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruited subjects will be patients referred by medical and surgical specialists involved in cancer management dementia epilepsy and cardiology

Brief summary: 18F-FDG produced in the MIRC NS has a similar safety profile to the same compound utilized elsewhere in that no significant adverse events will occur during observation of the patients for 2 1/2 hours post injection of the tracer. It is also hypothesized that as this FDG produced by similar methodology and its quality assurance assessed as in another jurisdictions will have similar performance parameters in patients with focal lung pathology to that previously determined.

Detailed description: Positron Emission Tomography (PET) utilizing 18F-FDG is a nuclear medicine imaging technique evaluating glucose related metabolic processes providing information not obtainable from anatomic imaging . 18F-FDG PET scanning is used clinically in most developed countries and Canadian jurisdictions primarily in oncology patients and also in assessing myocardial viability and some neurological conditions.

The functional information obtained from 18F-FDG PET has been demonstrated to have a significant impact on patient management in oncology.1 It is used to provide accurate pre-treatment staging, aid in planning of therapy, monitoring response to therapy, restaging, providing assessment of recurrence after curative therapy and in radiation treatment planning.

Patients with severe ischemic heart disease and secondary myocardial dysfunction pose difficult management decisions in terms of surgical vs. medical management. Assessment of viable myocardium is integral in this decision and 18F-FDG PET has been shown one of the most effective non-invasive methods in this evaluation.

18F-FDG PET has been shown very effective in neurology differentiating dementia types and in patients with epilepsy in whom surgical treatment is being considered.

The Capital District Health Authority (CDHA) PET/CT program has operated since June, 2008 and to date has examined over 2000 patients utilizing Health Canada approved 18F-FDG produced by Pharmalogic in Montreal. A significant component of the PET Program infrastructure in Nova Scotia is the Medical Imaging and Research Centre (MIRC NS) including a GMP grade radiopharmaceutical production lab and cyclotron. This CTA will allow evaluation of 18F-FDG produced at the MIRC-NS in a similar case load to prove its clinical utility and safety.

Eligibility criteria: Oncology

* Diagnosis to determine if a suspicious lesion is cancer
* Staging of confirmed cancer
* Evaluation of treatment response
* Follow up for cancer with high risk of recurrence
* Restaging following therapy
* Diagnosis of an unknown primary
* Assessment of potential paraneoplastic syndrome
* Radiation therapy planning

Neurology

18F-FDG PET will be used for evaluation of patients with

* Dementia, for differential diagnosis and prognosis
* Mild cognitive impairment, for suspected dementia
* Epilepsy, for localization of a seizure focus

Cardiology

• 18F-FDG PET in the evaluation of patients with ischemic heart disease and severely compromised myocardial function to aid in the evaluation of the appropriateness of revascularization.

General inclusion criteria:

* Diabetic patients are admissible, but will require proper control of their glucose levels (below 14) if possible prior to the scan.
* Receipt of an acceptably completed PET/CT scan requisition will be necessary.
* Patients will be able to tolerate the physical and logistic requirements of completing a PET scan including weight below 450lb and not claustrophobic to the extent that they can't tolerate being in the scanner gantry

EXCLUSION CRITERIA

* Pregnant women; if there is any possibility of pregnancy, a blood HCG level will be obtained
* Patients unwilling or unable to stop breast feeding for 24 hours
* Patients or guardians unwilling or unable to provide informed consent
* Patients who are medically unstable
* Patients who exceed the safe weight limit of the PET/CT bed or who cannot fit through the PET/CT gantry

Primary outcomes:
measure: Ensure the Safety profile of the Halifax produced FDG is similar to litature based findings
timeFrame: 3 hours post injection
Secondary outcomes:
measure: To effectively demonstrate diagnostic performance of the Halifax produced FDS in patients with focal lung pathology mirroring that previously published
timeFrame: 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: CapitalDHACanada
state: Nova Scotia
Study officials:
References: