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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05733416
- Acronym / sponsor ID
- INCOGNITO / 20230006-01H
- Conditions
- Occult Cancer
- Keywords
- cryptogenic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Brain Canada, Heart and Stroke Foundation of Canada, Canadian Stroke Consortium (CSC)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Cancer Screening | Experimental | Diagnostic Test: FDG PET/CTUsual care plus FDG PET/CT |
| Usual Care | Other | Diagnostic Test: Usual CareCancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG PET/CTF-fluorodeoxyglucose positron emission/computed tomography | Diagnostic test | Intensive Cancer Screening |
| Usual CareCancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care | Diagnostic test | Usual Care |
Primary outcome
Participant Recruitment
Time frame: Over 12 months
Number of participants recruited
5 secondary outcomes
Eligibility Rate
Time frame: Over 12 months
Consent Rate
Time frame: Over 12 months
Retention Rate
Time frame: Over 24 months
Study Completion Rate
Time frame: Over 24 months
Adherence Rate
Time frame: Over 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dariush Dowlatshahi, MD PhD principal investigator
Ottawa Hospital Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET/CT in people with Occult Cancer, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dariush Dowlatshahi, MD PhD (613-798-5555 ext. 14709, ddowlat@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment (time frame: Over 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.