Fluorocholine PET/CT Basket Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-fluorocholine PET/CT..
- Who it may be relevant to
- Registry conditions: Fluorocholine PET/CT. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Performance of 18F-Fluorocholine Positron Emission Tomography With Computed Tomography in Patients With 18F-Fluorocholine-avid Lesions: A Basket Trial
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.
Interventions
- Drug 18F-fluorocholine PET/CT.
18F-fluorocholine positron emission tomography / computed tomography
Primary outcome measures
- Diagnostic accuracy of Fluorocholine PET/CT [Time frame: 1 day]
Secondary outcome measures (1)
- Incidence of treatment-emergent adverse events following Fluorocholine PET/CT [Time frame: 30 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Jewish General Hospital — Montreal
Identifiers
NCT: NCT04150458 · FCH Basket