Status:
UNKNOWN
Implementation and Evaluation of Improved Access to Medical Imaging for Geriatric Patients of The Royal Ottawa Hospital
Lead Sponsor:
Tim Lau
Collaborating Sponsors:
McGill University
Conditions:
Dementia
Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
In this study, the investigators implement FDG-PET imaging for clients in the Geriatric Psychiatry department at The Royal Ottawa Hospital (ROH) and evaluate the impact of this advanced imaging techni...
Detailed Description
OVERVIEW The investigators will recruit 15 participants in the Geriatric Psychiatry department at the Royal Ottawa Hospital (ROH) who have an unclear diagnosis of dementia and their study partners. E...
Eligibility Criteria
Inclusion
- Participants are able to speak and read English.
- Participant or their Substitute Decision Maker (SDM) are able to provide written informed consent to participate in the study.
- Participants are able to comply with the requirements of the study.
- Participant has a study partner who will provide written informed consent to participate, is in frequent contact with the participant, will accompany the participant to FDG-PET study visit and will complete pre-/post-FDG-PET surveys.
- Participant has a diagnosis of a cognitive impairment.
- Participant has undergone a standard baseline clinical evaluation.
- Participant has undergone clinical structural brain imaging (MRI or CT).
- Structural brain imaging excluded an anatomical cause of the symptoms of cognitive impairment.
- Participant has been evaluated by a cognitive disorders specialist.
- Participant has an unclear underlying pathological process despite the above evaluations and the referring physician feels added clarity in the diagnosis has the potential to help with clinical management.
Exclusion
- Participant is not able to comply with the requirements of the study (including fasting for 6 hours, lying still in a supine position for 50 minutes).
- Participant an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth that cannot be safely removed.
- Participant has any contraindication to MRI or PET imaging.
- Participant has active malignancies. This is due to the high likelihood that the participant is or will be undergoing radiation therapy.
- Participant been exposed to other sources of radiation within the past year, where these bring their total radiation dose above the annual maximum.
- Female participants who are pregnant or breastfeeding. All female participants of childbearing potential will be required to have a negative urine pregnancy test on the day of the FDG-PET scan. Women are considered to be of childbearing potential if they are not permanently sterile or postmenopausal (12 consecutive months with no menses without an alternative medical cause).
- Participant has any other condition that, in the opinion of the investigator, could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05428475
Start Date
May 1 2023
End Date
May 15 2024
Last Update
March 6 2023
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