Prostate Cancer Imaging with [18Flourine]Prostate Specific Membrane Antigen (PSMA) PET: a study on pharmacokinetics and test repeatability

Phase 3

Completed

Conditions: prostate cancer
prostate malignancy
neoplasm of the prostate
10038597

Registration Number: NL-OMON45317

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>A pharmacokinetic model for [18F]PSMA and an appropriate simplified<br /><br>quantitative method.<br /><br><br /><br>Part B<br /><br>Test-retest variability of the simplified method of choice (part A) implemented<br /><br>in dynamic thoracic and WB [18F]PSMA PET/CT.</p><br>

Secondary Outcome Measures