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The PSMA-PET scan: a study on tracer properties and test repeatability

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24408
Enrollment
20
Registered
2017-05-26
Start date
2017-07-01
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

(metastasized) prostate cancer (gemetastaseerde) prostaatkanker

Interventions

Part A procedure consists of a 10 min PET study after intravenous (iv) administration of H215O, followed by a second 60 min PET study directly after [18F]PSMA administration. The procedure then includ

Sponsors

VU University Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Part A • Histologically proven prostate cancer, with lymphatic and/or haematogeneous metastases • Written informed consent • Per patient at least two metastases in the thorax, 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) • Diameter of one thoracic metastasis at least  1.5 cm (to minimize partial volume effects) • Patients able to remain supine for 90 minutes in the PET-CT scanner Part B • Histologically proven prostate cancer, with lymphatic and/or haematogeneous metastasis • Written informed consent • At least one metastasis (not necessarily thoracic) 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 (maximum) 90 minutes in the PET-CT scanner

Exclusion criteria

Exclusion criteria: • Claustrophobia (part A and B) • Multiple malignancies (part A and B) • Participation in part A (part B)

Design outcomes

Primary

MeasureTime frame
Part A: A pharmacokinetic model for [18F]PSMA ([18F]DCFPyl) and a validated simplified quantitative method for [18F]PSMA PET-CT. Part B: Test-retest variability of the derived simplified method (Part A).

Contacts

Public ContactBernard Jansen
bh.jansen@vumc.nl+31-20-44446033

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)