Fluorocholine PET/CT Basket Trial

Study Overview
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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.

Official Title
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Performance of 18F-Fluorocholine Positron Emission Tomography With Computed Tomography in Patients With 18F-Fluorocholine-avid Lesions: A Basket Trial

Conditions
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Fluorocholine PET/CT

Intervention / Treatment
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* Drug: 18F-fluorocholine PET/CT.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorocholine PET/CT<br>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. | Drug: 18F-fluorocholine PET/CT.<br>* 18F-fluorocholine positron emission tomography / computed tomography<br>* Other names: F-choline PET/CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events following Fluorocholine PET/CT | Unexpected immediate adverse events up to 30 minutes post-administration of 18F-fluorocholine. | 30 minutes |