The present study aims to:A) acquire a pharmacokinetic model of [18F]PSMA ([18F]-DCFPyl), by which simplified methods to quantify [18F]PSMA PET signal will be validated ; andB) assess the repeatability of those simplified quantitative method.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A
A pharmacokinetic model for [18F]PSMA and an appropriate simplified
quantitative method.
Part B
Test-retest variability of the simplified method of choice (part A) implemented
in dynamic thoracic and WB [18F]PSMA PET/CT.
Secondary outcome
not applicable
Background summary
[18F]Prostate Specific Membrane Antigen ([18F]PSMA) is a relatively new
oncological tracer used to perform Positron Emission Tomography * Computed
Tomography ([18F]PSMA PET-CT) scans. PSMA is a type II membrane glycoprotein
significantly overexpressed in prostate cancer cells. Presently, the main
application of this tracer is restaging in patients with prostate cancer (PCa).
In order monitor treatment response too, accurate quantification of [18F]PSMA
signal is important beyond visual image interpretation. For quantification of
PET tracers, full pharmacokinetic analysis is the golden 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. Therefore, simplified
measurements applicable with whole body scanning must be validated versus the
reference technique. Finally, to allow proper interpretation of signal changes
over time, the intrinsic repeatability of the simplified method of choice
should be defined. A better knowledge of the pharmacokinetics and repeatability
data could lead to an optimization of [18F]PSMA PET-CT diagnostic potential.
This might improve personalized therapy strategies for prostate cancer
patients.
Study objective
The present study aims to:
A) acquire a pharmacokinetic model of [18F]PSMA ([18F]-DCFPyl), by which
simplified methods to quantify [18F]PSMA PET signal will be validated ; and
B) assess the repeatability of those simplified quantitative method.
Study design
A mono-center, prospective observational study in 20 patients with
metastasized prostate cancer. The study consists of two parts: part A, the
[18F]PSMA pharmacokinetics, and part B, the repeatability of [18F]PSMA
estimates.
A. In the first part, both PSMA expression ([18F]PSMA) and perfusion
(H215O) will be measured quantitatively in 8 patients. 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]PSMA kinetics will be tested
in eight patients. Dynamic scanning will be performed on one occasion, using 2
tracers: H215O and [18F]PSMA.
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]PSMA PET-CT scan. For accurate reproducible measuring, a
dynamic PET-CT of the thorax region, will proceed the performing of the WB
scan.
Study burden and risks
The total amount of radiation burden will be lower than 8.5 mSv during the
entire part A study. The total amount of radiation burden for part B will not
exceed 18 mSv.
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Part;
- Histologically proven prostate cancer, with lymphatic and/or haematogeneous metastases;
- Written informed consent;
- At least 2 metastases in the thorax 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);
- At least one tumour (metastasis) with diameter * 1.5 cm (to minimize partial volume effects);
- Patients able to remain supine for 60 minutes in the PET-CT scanner;;Part B;
- Histologically proven prostate cancer, with lymphatic and/or haematogeneous metastases;
- Written informed consent;
- 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);
- Patients able to remain supine for 80 minutes in the PET-CT scanner;
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Claustrophobia (part A and B);
- Multiple malignancies (part A and B);
- Participation part A (Part B)
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 | EUCTR2017-000344-18-NL |
| CCMO | NL61224.029.17 |