Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO)

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Occult Cancer

Treatments: Diagnostic Test: FDG PET/CT; Diagnostic Test: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05733416

20230006-01H

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Intensive Cancer Screening

Experimental group

Description:

Usual care plus FDG PET/CT

Treatment:

Diagnostic Test: FDG PET/CT

Usual Care

Other group

Description:

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

Treatment:

Diagnostic Test: Usual Care