Fluorocholine PET/CT Basket Trial

NCT ID: NCT04150458

Last Updated: 2024-04-17

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

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2030-07-31

Brief Summary

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This is a single-arm, open-label, phase III trial in up to 2000 patients with known or suspected benign or malignant tumors which are known or suspected to be 18F-fluorocholine-avid.

Patients will receive regular standard clinical care. The only study-specific procedure will be the administration of 18F-fluorocholine followed by a PET/CT scan.

Diagnostic accuracy of 18F-fluorocholine PET/CT will be captured versus a composite clinical, radiological and histopathological standard of truth at follow-up.

Detailed Description

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Conditions

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Fluorocholine PET/CT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluorocholine PET/CT

The sole study-specific procedure is a single 18F-fluorocholine positron emission tomography / computed tomography (PET/CT). Subjects will receive 9 mCi 18F-fluorocholine IV, 5 to 120 minutes prior to PET/CT. 18F-fluorocholine PET/CT studies will be performed on hybrid PET/CT scanners which combine a dedicated, full-ring PET scanner with a multi-slice spiral CT scanner.

Group Type EXPERIMENTAL

18F-fluorocholine PET/CT.

Intervention Type DRUG

18F-fluorocholine positron emission tomography / computed tomography

Interventions

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18F-fluorocholine PET/CT.

18F-fluorocholine positron emission tomography / computed tomography

Intervention Type DRUG

Other Intervention Names

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FCH PET/CT F-choline PET/CT

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Under referring physician's care
* Able to understand and provide written informed consent
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation for injection
* Known or suspected benign or malignant tumor which is known or suspected to be 18F-fluorocholine-avid as per current medical literature

Exclusion Criteria

* Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
* Exceeding the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
* Unmanageable claustrophobia
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stephan Probst, MD

Chief of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan Probst, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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FCH Basket

Identifier Type: -

Identifier Source: org_study_id

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