Fluorocholine PET/CT Basket Trial

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

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04150458

Enrollment

2000

Registered

2019-11-04

Start date

2022-11-30

Completion date

2030-07-31

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluorocholine PET/CT

Brief summary

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

DRUG18F-fluorocholine PET/CT.

18F-fluorocholine positron emission tomography / computed tomography

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 110 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of Fluorocholine PET/CT	1 day	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.

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026