Implementation and Evaluation of Improved Access to Medical Imaging for Geriatric Patients of The Royal Ottawa Hospital
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Primary Endpoint
- Determine changes in clinician confidence in their differential diagnosis of clients with unclear symptoms of dementia.
Study Overview
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 technique on client care. This study is intended to provide supporting evidence for the continued use of FDG-PET imaging at the ROH BIC as a diagnostic support for the differential diagnosis of unclear dementia.
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. Each participant will have four study visits expected to take less than six months of involvement in total. The study partner is required to accompany the participant for all visits.
Visit 1: Informed consent and completion of pre-imaging questionnaires. Visit 2: Eligible participants undergo an FDG-PET scan at the Brain Imaging Centre (BIC).
Visit 3: Meeting with referring physician to review FDG-PET results. Visit 4: Completion of post-imaging questionnaires.
Wherever possible, Visits 1, 2 and 4 will be scheduled to coincide with regular clinical appointments. For participants who do not have decisional capacity, assent will be sought at each visit and recorded on the Continuing Consent/Assent study document. The study procedures will be described at a level that is understandable to the participant. This may mean describing one step at a time and seeking assent for that piece of the study in the moment. Both verbal and physical cues as well as feedback from the study partner will be used to support assent.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
[18F]FDG-PET Scan
Participants with unclear symptoms of cognitive impairment who will undergo the [18F]FDG-PET scan (185 MBq of [18F]FDG administered once during study).
Intervention: [18F]FDG-PET Scan (Diagnostic Test)
Outcomes
Primary Outcomes
Determine changes in clinician confidence in their differential diagnosis of clients with unclear symptoms of dementia.
Time Frame: At participation initiation for baseline measurement, 1 month, and 3 months
The study will measure clinician diagnostic confidence pre- and post- FDG-PET using the Referring Physician Pre-PET Survey and Referring Physician Post-PET Survey.
Determine changes in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time Frame: At participation initiation for baseline measurement and 3 months
The number of participants for whom a change in treatment plan occurred due to the added information from the FDG-PET scan, as reported on the Referring Physician Pre- and Post-PET Surveys, will be measured. Additionally, participant and study partner reported global impression of change over the course of the study will be tabulated to determine if any overall clinical improvement was observed (ADCS-CGIC). On the ADCS-CGIC, global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); and global change at follow-up scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change.
Identify changes in client treatment regiment as a result of access to FDG-PET imaging.
Time Frame: At participation initiation for baseline measurement and 3 months
Dichotomy measure of if the treatment regiment for the client was changed (success=1) or not changed (fail=0) as a result from the FDG-PET results.
Determine participant perceptions of access to medical imaging for patients of The Royal.
Time Frame: At participation initiation for baseline measurement and 3 months
Participants and their study partners will be asked about whether access to medical imaging affected their confidence in their treatment and diagnosis.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tim Lau
Clinical Lead, Geriatric Psychiatry Inpatient Unit
The Royal Ottawa Mental Health Centre