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Trial Title:
Intensive Cancer Screening After Cryptogenic Stroke
NCT ID:
NCT05733416
Condition:
Occult Cancer
Conditions: Official terms:
Ischemic Stroke
Conditions: Keywords:
cryptogenic stroke
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
FDG PET/CT
Description:
F-fluorodeoxyglucose positron emission/computed tomography
Arm group label:
Intensive Cancer Screening
Intervention type:
Diagnostic Test
Intervention name:
Usual Care
Description:
Cancer screening according to sex, age and risk as per Canadian Task Force on
Preventative Health Care
Arm group label:
Usual Care
Summary:
The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label
blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial
to determine whether an occult cancer screening strategy of FDG PET/CT in addition to
usual care increases the number of occult cancers diagnosed after screening compared to
usual care cancer screening alone in patients with cryptogenic stroke.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- adults ≥18 years
- presenting to the Ottawa Hospital Stroke Prevention Clinic or the Ottawa Hospital
Neurovascular Unit with a first cryptogenic ischemic stroke after advanced
evaluation as per American Heart Association guidelines and Saver approach (maximum
3 months after stroke)
- patient or delegate willing and able to provide informed consent.
Exclusion Criteria:
- contraindications to FDG PET/CT (pregnancy or unable to lie still in bed for 20
minutes)
- active cancer or previous cancer diagnosis (other than basal or squamous cell
carcinoma of the skin)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1Y 4E9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Michele Demetroff
Phone:
6137985555
Email:
mdemetrof@ohri.ca
Investigator:
Last name:
Dar Dowlatshahi, MD PhD
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Collaborator:
Agency:
Brain Canada
Agency class:
Other
Collaborator:
Agency:
Heart and Stroke Foundation of Canada
Agency class:
Other
Collaborator:
Agency:
Canadian Stroke Consortium (CSC)
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05733416
