Status:

COMPLETED

Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia

Lead Sponsor:

Nova Scotia Health Authority

Conditions:

18FDG

Eligibility:

All Genders

1+ years

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...

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 ....

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 19 2010

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    April 18 2017

    Estimated Enrollment :

    9463 Patients enrolled

    Trial Details

    Trial ID

    NCT01136720

    Start Date

    June 19 2010

    End Date

    April 18 2017

    Last Update

    August 21 2024

    Active Locations (1)

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    CapitalDHACanada

    Halifax, Nova Scotia, Canada, B3H1Y5

    Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia | DecenTrialz