Occult CancerINCOGNITONCT05733416
Intensive Cancer Screening After Cryptogenic Stroke
A study testing FDG PET/CT in people with Occult Cancer, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial 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 (F-fluorodeoxyglucose positron emission/computed tomography) in addition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occult Cancer
- What is being tested?
- FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Sep 2023to Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Not yet recruiting
Calgary Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Ronda Lun, MD, MSc, FRCPC, 403-944-4286, rlun@ucalgary.ca
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Laura Gioia, MD, MSc, 514-890-8000 ext. 26268, Laura.gioia@umontreal.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Michele Demetroff, 6137985555, mdemetrof@ohri.ca
Dariush Dowlatshahi, MD PhD
About this study
Official title: Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
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 (F-fluorodeoxyglucose positron emission/computed tomography) 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.
- Conditions
- Occult Cancer
- Being tested
- FDG PET/CT, Usual Care
- Keywords
- cryptogenic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CTDiagnostic test
F-fluorodeoxyglucose positron emission/computed tomography
Usual CareDiagnostic test
Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care
| Study group | Role | What they receive |
|---|---|---|
| Intensive Cancer Screening | Experimental | Usual care plus FDG PET/CT Receives: Diagnostic Test: FDG PET/CT |
| Usual Care | Other | Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care) Receives: Diagnostic Test: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment
Number of participants recruited
Measured: Over 12 months
Secondary outcomes (5)
Eligibility Rate
percentage of screened patients who are eligible
Measured: Over 12 months
Consent Rate
percentage of eligible patients who provide consent
Measured: Over 12 months
Retention Rate
percentage of participants retained at follow-up
Measured: Over 24 months
Study Completion Rate
percentage of participants who completed all study procedures
Measured: Over 24 months
Adherence Rate
adherence to screening strategy
Measured: Over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Sep 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occult CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada, Heart and Stroke Foundation of Canada, Canadian Stroke Consortium (CSC)
- Responsible party
- Sponsor
- Investigators
- Dariush Dowlatshahi, MD PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733416
- Sponsor's protocol ID
- 20230006-01H
- Acronym
- INCOGNITO
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No