drugset / Trial / NCT03101176
Multiparametric Ultrasound Imaging in Prostate Cancer
Unknown
200 enrolled
Academic Medical Center - University of Amsterdam
Amsterdam UMC, location VUmc · collab
NaSingle-groupOpen-labelDiagnostic
Summary
Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality combining different ultrasound parameters, heralds the potential for an accurate imaging-based diagnostic approach accessible to the community at large but formal validation of mpUS against final pathology results are still lacking. Objective: To validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology of radical prostatectomy specimens
Timeline
- Start
- 2017-09-07
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
Publications
- Background Bjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, Wheeler TM, Schlossberg S, Penson DF, Taneja SS. Optimization of initial prostate biopsy in clinical practice: sampling, labeling and specimen processing. J Urol. 2013 Jun;189(6):2039-46. doi: 10.1016/j.juro.2013.02.072. Epub 2013 Feb 26.
- Background Ukimura O, Coleman JA, de la Taille A, Emberton M, Epstein JI, Freedland SJ, Giannarini G, Kibel AS, Montironi R, Ploussard G, Roobol MJ, Scattoni V, Jones JS. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol. 2013 Feb;63(2):214-30. doi: 10.1016/j.eururo.2012.09.033. Epub 2012 Sep 25.
- Background Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.
- Background Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MG. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol. 2015 Sep;68(3):438-50. doi: 10.1016/j.eururo.2014.11.037. Epub 2014 Dec 3.
- Background Muller BG, Shih JH, Sankineni S, Marko J, Rais-Bahrami S, George AK, de la Rosette JJ, Merino MJ, Wood BJ, Pinto P, Choyke PL, Turkbey B. Prostate Cancer: Interobserver Agreement and Accuracy with the Revised Prostate Imaging Reporting and Data System at Multiparametric MR Imaging. Radiology. 2015 Dec;277(3):741-50. doi: 10.1148/radiol.2015142818. Epub 2015 Jun 18.
- Background Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.
- Background Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
- Background Grey A, Ahmed HU. Multiparametric ultrasound in the diagnosis of prostate cancer. Curr Opin Urol. 2016 Jan;26(1):114-9. doi: 10.1097/MOU.0000000000000245.
- Background Postema A, Mischi M, de la Rosette J, Wijkstra H. Multiparametric ultrasound in the detection of prostate cancer: a systematic review. World J Urol. 2015 Nov;33(11):1651-9. doi: 10.1007/s00345-015-1523-6. Epub 2015 Mar 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumason | Diagnostic / imaging agent | — | Intravenous |