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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45317
Enrollment
20
Registered
2017-11-28
Start date
2018-01-26
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

prostate cancer

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)