Screening for hidden cancers in patients with unexplained strokes
Official title: Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
Run by Ottawa Hospital Research Institute · NCT05733416 · Data updated 2026-11-12
This study is testing if adding special scans to regular cancer checks can help find hidden cancers in people who have had unexplained strokes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 3 sites (Calgary, Alberta and 2 other locations) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT05733416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have had a first cryptogenic ischemic stroke and are able to provide informed consent.
✕Probably not a fit
Patients with active cancer or a history of cancer (excluding certain skin cancers) will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The INCOGNITO Pilot Trial is designed to evaluate the feasibility of a larger randomized trial that investigates whether adding FDG PET/CT scans to standard cancer screening improves the detection of occult cancers in patients who have experienced a cryptogenic stroke. This single-center, prospective trial will compare the outcomes of patients receiving enhanced screening versus those receiving usual care. The goal is to determine if this approach can lead to earlier diagnosis and treatment of hidden cancers that may be present in these patients.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of occult cancers in patients who have suffered a cryptogenic stroke, potentially improving their prognosis.
How similar studies have gone: While this approach is innovative, it is not widely tested, making this study a novel exploration in the field.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
The Ottawa Hospital
Ottawa, Ontario, Canada Recruiting -
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada Recruiting -
Calgary Foothills Medical Centre
Calgary, Alberta, Canada Not yet recruiting
Study contacts
- Principal investigator: Dariush Dowlatshahi, MD PhD — Ottawa Hospital Research Institute
- Study coordinator: Dariush Dowlatshahi, MD PhD
- Email: ddowlat@toh.ca
- Phone: 613-798-5555
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.