Recruiting

Cancer Screening

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05733416

Conditions

Occult Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FDG PET/CT

Usual Care

Study Details

Brief 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 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

Study ID

NCT05733416

Start date

Sep 1, 2023

Status verified date

Jul, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Intensive Cancer Screening

Usual care plus FDG PET/CT

other: Usual Care

Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care)

Interventions

FDG PET/CT

F-fluorodeoxyglucose positron emission/computed tomography

Usual Care

Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care

Primary outcome measure

  • Participant Recruitment [ Time Frame: Over 12 months ]

Central Contacts and Locations

Central contacts

Dariush Dowlatshahi, MD PhD

613-798-5555ddowlat@toh.ca

Deborah Siegal, MD

613-737-8899dsiegal@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Michele Demetroff

6137985555mdemetrof@ohri.ca

Principal Investigator:

Dariush Dowlatshahi, MD PhD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • cryptogenic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-31.