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OpenTrials
Enrolling by Invitation

NCT Number: NCT04150458

Fluorocholine PET/CT Basket Trial

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.

Enrolling by Invitation

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Key information

Conditions

Fluorocholine PET/CT

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-fluorocholine PET/CT.

Drug

18F-fluorocholine positron emission tomography / computed tomography

Other names: FCH PET/CT, F-choline PET/CT

Primary outcomes

  1. Diagnostic accuracy of Fluorocholine PET/CT

    Time frame: 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 outcomes

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

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Nov 4, 2019
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.