To improve detection of metastases, radiotracers have been developed for PET/CT imaging: i.e. radiolabelled Prostate Specific Membrane Antigen (PSMA) ligands. Initial studies with Gallium-68 (68Ga-) PSMA showed promising results. The second…
ID
Bron
Verkorte titel
Aandoening
intermediate-high risk prostate cancer, primary staging, diagnostics
Ondersteuning
Weg door Jonkerbos 100
6532 SZ Nijmegen
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Diagnostic accuracy (sensitivity, specificity, PPV and NPV) of 18F-PSMA-1007 PET/CT for the detection of (regional) lymph node metastases in the initial staging of intermediate-to high risk PCa patients.
Achtergrond van het onderzoek
Over the last years, PSMA-targeting imaging strategies are gaining prominence and have been introduced into (inter)national clinical practice for both initial staging and restaging of PCa. Both 68Ga-PSMA and 18F-labelled PSMA ligands appear safe, provide intense tumor uptake and high tumor-to-background ratios, allowing high lesion detectability. However, diagnostic accuracy of the newly developed 18F-PSMA-1007 tracer has not been extensively investigated. Hence, this study aims to determine diagnostic performance of 18F-PSMA-1007 PET/CT in detection of lymph node metastases as compared to histopathological examination following PLND.
Doel van het onderzoek
To improve detection of metastases, radiotracers have been developed for PET/CT imaging: i.e. radiolabelled Prostate Specific Membrane Antigen (PSMA) ligands. Initial studies with Gallium-68 (68Ga-) PSMA showed promising results. The second generation of Fluorine-18 labelled (18F-) PSMA is hypothesized to offer even better diagnostics. Compared to 68Ga-PSMA, 18F-PSMA has a higher image resolution and a longer half-life. The present study therefore aims to determine diagnostic accuracy of 18F-PSMA-1007 PET/CT in initial staging of intermediate- to high risk PCa.
Onderzoeksopzet
Inclusion of patients: 1-1-2019 up to 1-1-2020.
Data analysis: 1-1-2010 up to 1-6-2010
Publication of data: 1-10-2020
Onderzoeksproduct en/of interventie
Not applicable
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Biopsy proven adenocarcinoma of the prostate;
2. Indication for (super)extended pelvic lymph node dissection (PLND - with or without robot-assisted laparoscopic prostatectomy);
3. Mentally competent and understanding of benefits and potential burden of the study;
4. Written informed consent;
5. Age ¡Ý18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. History of prior diagnosed or treated PCa.
2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
3. Unwillingness or inability to undergo 18F-PSMA-1007 PET/CT.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7428 |
| NTR-old | NTR7670 |
| Ander register | 2018-4294 : CMO dossiernummer |