Fluorocholine PET/CT Basket Trial

Phase 3Enrolling By InvitationNCT04150458

Sir Mortimer B. Davis - Jewish General Hospital2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,000

Conditions

Fluorocholine PET/CT

Interventions

18F-fluorocholine PET/CT.DRUG

18F-fluorocholine positron emission tomography / computed tomography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Diagnostic accuracy of Fluorocholine PET/CT

Sensitivity, specificity, positive predictive and negative predictive values of 18F-fluorocholine PET/CT in the detection of tumor lesions as compared to a composite truth standard.

Time frame: 1 day

Secondary Outcomes

Incidence of treatment-emergent adverse events following Fluorocholine PET/CT

Unexpected immediate adverse events up to 30 minutes post-administration of 18F-fluorocholine.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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