Intensive Cancer Screening After Cryptogenic Stroke

NCT ID: NCT05733416

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Occult Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive Cancer Screening

Usual care plus FDG PET/CT

Group Type EXPERIMENTAL

FDG PET/CT

Intervention Type DIAGNOSTIC_TEST

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)

Group Type OTHER

Usual Care

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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FDG PET/CT

F-fluorodeoxyglucose positron emission/computed tomography

Intervention Type DIAGNOSTIC_TEST

Usual Care

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain Canada

OTHER

Sponsor Role collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Canadian Stroke Consortium (CSC)

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dariush Dowlatshahi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dariush Dowlatshahi, MD PhD

Role: CONTACT

613-798-5555 ext. 14709

Deborah Siegal, MD

Role: CONTACT

613-737-8899 ext. 78060

Facility Contacts

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Michele Demetroff

Role: primary

6137985555

Other Identifiers

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20230006-01H

Identifier Type: -

Identifier Source: org_study_id

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