Intensive Cancer Screening After Cryptogenic Stroke

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05733416
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ottawa Hospital Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Occult Cancer
Arms & Interventions

Arms

Experimental: Intensive Cancer Screening

Usual care plus PDG PET/CT

Other: Usual Care

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

Interventions

Diagnostic Test: - FDG PET/CT

F-fluorodeoxyglucose positron emission/computed tomography

Diagnostic Test: - Usual Care

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Ottawa Hospital, Ottawa, Ontario, Canada

Status

Recruiting

Address

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9

Site Contact

Michele Demetroff

[email protected]

6137985555

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