Een studie naar farmacokinetiek en reproduceerbaarheid van 18Fluor -gelabelde choline in patienten met prostaat kanker.

A study on the pharmacokinetics and repeatability of [18F]Fluoromethylcholine PET-CT in patients with Prostate Cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26086

Enrollment

Registered

2012-05-16

Start date

2012-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Keywords English: pharmacokinetics, repeatability, PET, choline, prostate cancer, kinetic model, standardised uptake value (SUV), region of interst (ROI), volume of interest (VOI). Dutch: farmacokinetiek, reproduceerbaarheid, PET, choline, prostaat kanker, kinetiek model, SUV, ROI, VOI.

Interventions

This is a single centre, prospective, observational study in patients with metastasized Prostate cancer. Part A: Performing of dynamic scans of the target region involving metstases, together with

Eligibility

Inclusion criteria

Inclusion criteria: Part A: 1. Histologically proven prostate cancer, with lymphatic and/or haematogeneous metastases; 2. Written informed consent; 3. At least 2 tumours (metastases) per patient detected by conventional imaging (e.g., bone scan, either CT or MRI of the chest, abdomen and pelvis); conventional imaging should be recently performed (no longer than 3 months previous to the PET-CT scan); 4. At least one tumour (metastasis) with diameter 1.5 cm (to minimize partial volume effects); 5. Patients able to remain supine for 50 minutes in the PET-CT scanner. Part B: 1. Histologically proven prostate cancer, with lymphatic and/or haematogeneous metastases; 2. Written informed consent; 3. At least one tumour (metastasis) with diameter > 1.5 cm detected by recently performed conventional imaging (maximal 3 months prior to the PET-CT scan); 4. Patients able to remain supine for 40 minutes in the PET-CT scanner.

Exclusion criteria

Exclusion criteria: 1. Claustrophobia (part A and B); 2. Multiple malignancies (part A and B); 3. Anticoagulant therapy (part A).

Design outcomes

Primary

Measure	Time frame
Part A: A pharmacokinetic model for [18F]FCH. Part B: Test-retest variability of the simplified method of choice (part A) implemented in WB [18F]FCH PET-CT.	—

Secondary

Measure	Time frame
Part A: Selection of an appropriate simplified quantitative method for use of [18F]FCH in clinical practice.	—

Contacts

Public ContactD.E. Oprea-Lager

Department of Nuclear medicine and PET research de Boelelaan 1117 PO Box 7057

d.oprea-lager@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)