The aims of the present study are: 1. to create a tracer kinetic model for quantification of [18F]FCH and simultaneously validate a simplified quantitative method, and 2. to assess the repeatability of the latter method.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A: A pharmacokinetic model for [18F]FCH and an appropriate simplified
quantitative method.
Part B: Test-retest variability of the simplified method of choice (part A)
implemented in WB [18F]FCH PET-CT.
Secondary outcome
To identify an appropriate simplified quantitative method for clinical
practice.
Background summary
[18F]Fluoromethylcholine ([18F]FCH) is a relatively new oncological tracer used
to perform Positron Emission Tomography * Computed Tomography ([18F]FCH PET-CT)
scans.
The main application of this tracer is restaging in patients with prostate
cancer (PCa). For response evaluation, accurate quantification of the [18F]FCH
signal is important beyond visual image interpretation.
For quantification of PET tracers, non-linear regression analysis is the gold
standard. However, its complexity makes it unsuitable for application in daily
clinical practice; moreover, it is not compatible with the whole body
acquisitions typically required in patients with metastasised disease.
Simplified measures applicable in whole body settings can be validated versus
the reference technique.
Finally, to allow proper interpretation of signal changes over time, the
repeatability of the simplified method of choice should be defined.
Study objective
The aims of the present study are: 1. to create a tracer kinetic model for
quantification of [18F]FCH and simultaneously validate a simplified
quantitative method, and 2. to assess the repeatability of the latter method.
Study design
A monocenter, prospective observational study in 20 patients with metastasized
prostate cancer. The study consists of two parts: part A, the [18F]FCH
pharmacokinetics, and part B, the repeatability of [18F]FCH estimates.
A. In the first part, both cell membrane proliferation ([18F]FCH) and
perfusion (H215O) will be measured quantitatively. Accuracy of blood and plasma
activity concentration, plasma metabolite measurements derived from arterial
and venous samples as well the reliability of using Image Derived Input
Functions (IDIF) for quantification of [18F]FCH kinetics will be tested in
eight patients. Dynamic scanning will be performed on one occasion, using 2
tracers: H215O and [18F]FCH.
B. In the second step of the protocol, depending on the obtained validation in
part A, the repeatability of the method will be tested in 12 other patients, on
two separate occasions (at most one week apart) using a whole body (WB)
[18F]FCH PET-CT scan.
Study burden and risks
The total amount of radiation burden will be lower than 4.5 mSv during the
entire part A study. The total amount of radiation burden for part B will not
exceed 14 mSv.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Part A:
1. Histologically proven metastasised prostate cancer
2. Written informed consent
3. At least 2 tumours (metastases) per patient detected by conventional imaging (e.g., bone scan, CT or MRI of the chest, abdomen or pelvic region); conventional imaging should be recently performed (no longer than 3 months previous to the PET-CT scan)
4. At least one tumour (metastasis) with a diameter equal or more than 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 metastasised prostate cancer
2. Written informed consent
3. At least one tumour (metastasis) with a diameter equal or more than 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 60 minutes in the PET-CT scanner
Exclusion criteria
1. Claustrophobia (part A and B);
2. Multiple malignancies (part A and B);
3. Anticoagulant therapy (part A).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002442-20-NL |
| CCMO | NL40899.029.12 |