Prostate CancerNCT06244680
Super-fast 3T Prostate MRI Using High Gradient Strength and Deep Learning
An observational study of Prostate Cancer, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Recent developments in MRI techniques allow ultra-high gradient strength diffusion imaging and deep learning (DL) reconstruction in clinical routine. However, its usability in biparametric MRI (bpMRI) of the prostate has not been well studied. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI of the prostate
- Type of treatment
- Medical device
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of male patients with clinical suspicion for prostate cancer, as described by the inclusion criteria.
Who may be able to join
- Elevated PSA >4ng/ml or suspicious digitial rectal exam or supicious transrectal ultrasound
Who cannot join
- General MRI contraindications (incompatible cardiac pacemaker, neurostimulators) or allergy for gadolinium-containing contrast media or severe claustrophobie
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127
About this study
Official title: Super-fast 3T Prostate MRI Using High Gradient Strength and Deep Learning: Initial Experience
Recent developments in MRI techniques allow ultra-high gradient strength diffusion imaging and deep learning (DL) reconstruction in clinical routine. However, its usability in biparametric MRI (bpMRI) of the prostate has not been well studied. The aim is to establish a super-fast 3-minutes bpMRI protocol at 3 Tesla using high gradient strength and DL reconstruction and compare it against a full, multiparametric MRI (mpMRI) protocol.
Read the detailed description
Multiparametric MRI (mpMRI) of the prostate has become the most important non-invasive diagnostic tool for assessment of prostate cancer and is the baseline for MRI targeted biopsy (1,2). As the incidence of prostate cancer is high with an estimated 290,000 new cases for 2023 in the United States alone (3), the need for widespread provision of prostate mpMRI is immense. However, current clinical MRI-protocols are long with acquisition times of >30 minutes, potentially limiting the number of examined patients. According to the guidelines of the Prostate Imaging Reporting and Data System (PI-RADS) a sufficient mpMRI protocol must include diffusion weighted imaging (DWI), T2-weighted (T2w) imaging, dynamic contrast enhanced imaging and T1-weighted imaging pre and post administration of contrast (4,5). Different approaches have been developed to shorten the protocol itself or to accelerate acquisition times. For instance, a significant reduction of T2w-sequence acquisition times was achieved by employing deep learning methods (6) or advancements of compressed sensing (7), while at the same time images had improved quality. Different studies showed equal performance of biparametric MRI (bpMRI) protocols compared to the standard multiparametric protocol, effectively reducing the acquisition time down to 5 minutes (8,9,10). This was done by focusing only on DWI and T2w imaging while omitting the dynamic contrast enhanced sequence and T1-weighted sequences, as the additional diagnostic value of these is supposed to be limited (11).
Recent developments in MRI techniques allow for ultra-high diffusion gradient strengths of up to 500 mT/m and slew rates of up to 600 T/m/s, thus reducing echo times and acquisition times by faster establishment of the diffusion gradient (12,13). Furthermore, these gradients are able to image at small scales with a high signal-to-noise ratio, consecutively enhancing sensitivity for detection of tissue microstructures (14,15). Due to the experimental nature of these gradients, this technique has only been investigated in a research setting in healthy volunteers (16), but not in a real world clinical setting, let alone in prostate imaging.
Therefore, the aim of the study was to establish a super-fast abbreviated bpMRI protocol for patients with suspicion for prostate cancer using both ultra-high gradients and deep learning reconstruction for DWI- and T2w-sequences. Besides the assessment of acquisition times, the main objective of this study was to assess the overall image quality of bpMRI and mpMRI and the influence on PI-RADS scores.
- Conditions
- Prostate Cancer
- Being tested
- MRI of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the prostateDevice
Patients with suspicion for prostate cancer underwent mpMRI on a new 3-Tesla-MRI scanner with a maximum gradient strength of 200 mT/m, a slew rate of 200 T/m/s and DL reconstruction for image postprocessing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of PI-RADS scores
Three radiologists with 3, 11 and 12 years of experience in prostate MRI read separately and blinded to personal and clinical parameters (name, age, patient history, value of the prostate specific antigen, clinical examination and transrectal ultrasound) the full bpMRI protocol and graded the lesions according to the PI-RADS classification. Per patient, only the highest graded lesion and its respective prostate zone was noted. If there were two distinct lesions with the highest PI-RADS score in both the peripheral and transitional zone, both were noted. After a washout period of one month all readers did the same for the mpMRI protocol. Both the agreement of biparametric and multiparametric MRI PI-RADS scores for the whole prostate, and for the specific zonal distribution (peripheral and transitional zone) were assessed by calculation of Cohens's κ, interpreted as follows: <0.5 = poor; 0.5-0.75 = moderate; 0.75-0.9 = good; >0.9 = excellent.
Measured: January - February 2024
Acquisition time
Acquisition times for the whole biparametric and whole multiparametric protocol was measured.
Measured: January - February 2024
Image quality
Two raters with 3 and 11 years of experience rated the bpMRI protocol on a five point Likert scale in six different qualitative categories (artifacts, image sharpness, lesion conspicuity, capsule delineation, overall image sharpness and diagnostic confidence). The grades were defined as follows: 1, non-diagnostic due to extensive artifacts, strongly impaired conspicuity of anatomical structures and no diagnostic confidence; 2, several artifacts, difficult conspicuity of anatomical structures and low diagnostic confidence; 3, moderate artifacts, fair conspicuity of anatomical structures and moderate diagnostic confidence; 4, little artifacts, good conspicuity of anatomical structures and good diagnostic confidence; 5, no artifacts, excellent conspicuity of anatomical structures and high diagnostic confidence. Results of both raters were averaged.
Measured: January - February 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Alexander Luetkens, University Hospital, Bonn
- Investigators
- Julian A Luetkens, PD Dr. med, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244680
- Sponsor's protocol ID
- CX.001
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hugosson J, Mansson M, Wallstrom J, Axcrona U, Carlsson SV, Egevad L, Geterud K, Khatami A, Kohestani K, Pihl CG, Socratous A, Stranne J, Godtman RA, Hellstrom M; GOTEBORG-2 Trial Investigators. Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only. N Engl J Med. 2022 Dec 8;387(23):2126-2137. doi: 10.1056/NEJMoa2209454.
PubMed 36477032Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.
PubMed 34237810Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
PubMed 36633525ACR, ESUR and AdMeTech Foundation. Prostate Imaging Reporting & Data System (PI-RADS). 2019. Version 2.1.
Hegde JV, Mulkern RV, Panych LP, Fennessy FM, Fedorov A, Maier SE, Tempany CM. Multiparametric MRI of prostate cancer: an update on state-of-the-art techniques and their performance in detecting and localizing prostate cancer. J Magn Reson Imaging. 2013 May;37(5):1035-54. doi: 10.1002/jmri.23860.
PubMed 23606141Bischoff LM, Peeters JM, Weinhold L, Krausewitz P, Ellinger J, Katemann C, Isaak A, Weber OM, Kuetting D, Attenberger U, Pieper CC, Sprinkart AM, Luetkens JA. Deep Learning Super-Resolution Reconstruction for Fast and Motion-Robust T2-weighted Prostate MRI. Radiology. 2023 Sep;308(3):e230427. doi: 10.1148/radiol.230427.
PubMed 37750774Bischoff LM, Katemann C, Isaak A, Mesropyan N, Wichtmann B, Kravchenko D, Endler C, Kuetting D, Pieper CC, Ellinger J, Weber O, Attenberger U, Luetkens JA. T2 Turbo Spin Echo With Compressed Sensing and Propeller Acquisition (Sampling k-Space by Utilizing Rotating Blades) for Fast and Motion Robust Prostate MRI: Comparison With Conventional Acquisition. Invest Radiol. 2023 Mar 1;58(3):209-215. doi: 10.1097/RLI.0000000000000923. Epub 2022 Sep 2.
PubMed 36070533Weiss J, Martirosian P, Notohamiprodjo M, Kaufmann S, Othman AE, Grosse U, Nikolaou K, Gatidis S. Implementation of a 5-Minute Magnetic Resonance Imaging Screening Protocol for Prostate Cancer in Men With Elevated Prostate-Specific Antigen Before Biopsy. Invest Radiol. 2018 Mar;53(3):186-190. doi: 10.1097/RLI.0000000000000427.
PubMed 29077588Scialpi M, Prosperi E, D'Andrea A, Martorana E, Malaspina C, Palumbo B, Orlandi A, Falcone G, Milizia M, Mearini L, Aisa MC, Scialpi P, DE Dominicis C, Bianchi G, Sidoni A. Biparametric versus Multiparametric MRI with Non-endorectal Coil at 3T in the Detection and Localization of Prostate Cancer. Anticancer Res. 2017 Mar;37(3):1263-1271. doi: 10.21873/anticanres.11443.
PubMed 28314291Rais-Bahrami S, Siddiqui MM, Vourganti S, Turkbey B, Rastinehad AR, Stamatakis L, Truong H, Walton-Diaz A, Hoang AN, Nix JW, Merino MJ, Wood BJ, Simon RM, Choyke PL, Pinto PA. Diagnostic value of biparametric magnetic resonance imaging (MRI) as an adjunct to prostate-specific antigen (PSA)-based detection of prostate cancer in men without prior biopsies. BJU Int. 2015 Mar;115(3):381-8. doi: 10.1111/bju.12639. Epub 2014 Sep 15.
PubMed 24447678De Visschere P, Lumen N, Ost P, Decaestecker K, Pattyn E, Villeirs G. Dynamic contrast-enhanced imaging has limited added value over T2-weighted imaging and diffusion-weighted imaging when using PI-RADSv2 for diagnosis of clinically significant prostate cancer in patients with elevated PSA. Clin Radiol. 2017 Jan;72(1):23-32. doi: 10.1016/j.crad.2016.09.011. Epub 2016 Oct 7.
PubMed 27726850Huang SY, Witzel T, Keil B, Scholz A, Davids M, Dietz P, Rummert E, Ramb R, Kirsch JE, Yendiki A, Fan Q, Tian Q, Ramos-Llorden G, Lee HH, Nummenmaa A, Bilgic B, Setsompop K, Wang F, Avram AV, Komlosh M, Benjamini D, Magdoom KN, Pathak S, Schneider W, Novikov DS, Fieremans E, Tounekti S, Mekkaoui C, Augustinack J, Berger D, Shapson-Coe A, Lichtman J, Basser PJ, Wald LL, Rosen BR. Connectome 2.0: Developing the next-generation ultra-high gradient strength human MRI scanner for bridging studies of the micro-, meso- and macro-connectome. Neuroimage. 2021 Nov;243:118530. doi: 10.1016/j.neuroimage.2021.118530. Epub 2021 Aug 28.
PubMed 34464739Fan Q, Eichner C, Afzali M, Mueller L, Tax CMW, Davids M, Mahmutovic M, Keil B, Bilgic B, Setsompop K, Lee HH, Tian Q, Maffei C, Ramos-Llorden G, Nummenmaa A, Witzel T, Yendiki A, Song YQ, Huang CC, Lin CP, Weiskopf N, Anwander A, Jones DK, Rosen BR, Wald LL, Huang SY. Mapping the human connectome using diffusion MRI at 300 mT/m gradient strength: Methodological advances and scientific impact. Neuroimage. 2022 Jul 1;254:118958. doi: 10.1016/j.neuroimage.2022.118958. Epub 2022 Feb 23.
PubMed 35217204Setsompop K, Kimmlingen R, Eberlein E, Witzel T, Cohen-Adad J, McNab JA, Keil B, Tisdall MD, Hoecht P, Dietz P, Cauley SF, Tountcheva V, Matschl V, Lenz VH, Heberlein K, Potthast A, Thein H, Van Horn J, Toga A, Schmitt F, Lehne D, Rosen BR, Wedeen V, Wald LL. Pushing the limits of in vivo diffusion MRI for the Human Connectome Project. Neuroimage. 2013 Oct 15;80:220-33. doi: 10.1016/j.neuroimage.2013.05.078. Epub 2013 May 24.
PubMed 23707579McNab JA, Edlow BL, Witzel T, Huang SY, Bhat H, Heberlein K, Feiweier T, Liu K, Keil B, Cohen-Adad J, Tisdall MD, Folkerth RD, Kinney HC, Wald LL. The Human Connectome Project and beyond: initial applications of 300 mT/m gradients. Neuroimage. 2013 Oct 15;80:234-45. doi: 10.1016/j.neuroimage.2013.05.074. Epub 2013 May 24.
PubMed 23711537
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-fast 3T Prostate MRI Using High Gradient Strength and Deep Learning: Initial Experience
- ClinicalTrials.gov ID
- NCT06244680
- Acronym / sponsor ID
- CX.001
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent developments in MRI techniques allow ultra-high gradient strength diffusion imaging and deep learning (DL) reconstruction in clinical routine. However, its usability in biparametric MRI (bpMRI) of the prostate has not been well studied. The aim is to establish a super-fast 3-minutes bpMRI protocol at 3 Tesla using high gradient strength and DL reconstruction and compare it against a full, multiparametric MRI (mpMRI) protocol.
Detailed description
Multiparametric MRI (mpMRI) of the prostate has become the most important non-invasive diagnostic tool for assessment of prostate cancer and is the baseline for MRI targeted biopsy (1,2). As the incidence of prostate cancer is high with an estimated 290,000 new cases for 2023 in the United States alone (3), the need for widespread provision of prostate mpMRI is immense. However, current clinical MRI-protocols are long with acquisition times of >30 minutes, potentially limiting the number of examined patients. According to the guidelines of the Prostate Imaging Reporting and Data System (PI-RADS) a sufficient mpMRI protocol must include diffusion weighted imaging (DWI), T2-weighted (T2w) imaging, dynamic contrast enhanced imaging and T1-weighted imaging pre and post administration of contrast (4,5). Different approaches have been developed to shorten the protocol itself or to accelerate acquisition times. For instance, a significant reduction of T2w-sequence acquisition times was achieved by employing deep learning methods (6) or advancements of compressed sensing (7), while at the same time images had improved quality. Different studies showed equal performance of biparametric MRI (bpMRI) protocols compared to the standard multiparametric protocol, effectively reducing the acquisition time down to 5 minutes (8,9,10). This was done by focusing only on DWI and T2w imaging while omitting the dynamic contrast enhanced sequence and T1-weighted sequences, as the additional diagnostic value of these is supposed to be limited (11).
Recent developments in MRI techniques allow for ultra-high diffusion gradient strengths of up to 500 mT/m and slew rates of up to 600 T/m/s, thus reducing echo times and acquisition times by faster establishment of the diffusion gradient (12,13). Furthermore, these gradients are able to image at small scales with a high signal-to-noise ratio, consecutively enhancing sensitivity for detection of tissue microstructures (14,15). Due to the experimental nature of these gradients, this technique has only been investigated in a research setting in healthy volunteers (16), but not in a real world clinical setting, let alone in prostate imaging.
Therefore, the aim of the study was to establish a super-fast abbreviated bpMRI protocol for patients with suspicion for prostate cancer using both ultra-high gradients and deep learning reconstruction for DWI- and T2w-sequences. Besides the assessment of acquisition times, the main objective of this study was to assess the overall image quality of bpMRI and mpMRI and the influence on PI-RADS scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of male patients with clinical suspicion for prostate cancer, as described by the inclusion criteria.
Key inclusion criteria (1 listed)
- Elevated PSA >4ng/ml or suspicious digitial rectal exam or supicious transrectal ultrasound
Key exclusion criteria (1 listed)
- General MRI contraindications (incompatible cardiac pacemaker, neurostimulators) or allergy for gadolinium-containing contrast media or severe claustrophobie
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the prostatePatients with suspicion for prostate cancer underwent mpMRI on a new 3-Tesla-MRI scanner with a maximum gradient strength of 200 mT/m, a slew rate of 200 T/m/s and DL reconstruction for image postprocessing. | Device | – |
Primary outcome
Agreement of PI-RADS scores
Time frame: January - February 2024
Three radiologists with 3, 11 and 12 years of experience in prostate MRI read separately and blinded to personal and clinical parameters (name, age, patient history, value of the prostate specific antigen, clinical examination and transrectal ultrasound) the full bpMRI protocol and graded the lesions according to the PI-RADS classification. Per patient, only the highest graded lesion and its respective prostate zone was noted. If there were two distinct lesions with the highest PI-RADS score in both the peripheral and transitional zone, both were noted. After a washout period of one month all readers did the same for the mpMRI protocol. Both the agreement of biparametric and multiparametric MRI PI-RADS scores for the whole prostate, and for the specific zonal distribution (peripheral and transitional zone) were assessed by calculation of Cohens's κ, interpreted as follows: <0.5 = poor; 0.5-0.75 = moderate; 0.75-0.9 = good; >0.9 = excellent.
Acquisition time
Time frame: January - February 2024
Acquisition times for the whole biparametric and whole multiparametric protocol was measured.
Image quality
Time frame: January - February 2024
Two raters with 3 and 11 years of experience rated the bpMRI protocol on a five point Likert scale in six different qualitative categories (artifacts, image sharpness, lesion conspicuity, capsule delineation, overall image sharpness and diagnostic confidence). The grades were defined as follows: 1, non-diagnostic due to extensive artifacts, strongly impaired conspicuity of anatomical structures and no diagnostic confidence; 2, several artifacts, difficult conspicuity of anatomical structures and low diagnostic confidence; 3, moderate artifacts, fair conspicuity of anatomical structures and moderate diagnostic confidence; 4, little artifacts, good conspicuity of anatomical structures and good diagnostic confidence; 5, no artifacts, excellent conspicuity of anatomical structures and high diagnostic confidence. Results of both raters were averaged.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 36477032Hugosson J, Mansson M, Wallstrom J, Axcrona U, Carlsson SV, Egevad L, Geterud K, Khatami A, Kohestani K, Pihl CG, Socratous A, Stranne J, Godtman RA, Hellstrom M; GOTEBORG-2 Trial Investigators. Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only. N Engl J Med. 2022 Dec 8;387(23):2126-2137. doi: 10.1056/NEJMoa2209454.
- Background: PubMed 34237810Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.
- Background: PubMed 36633525Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- BackgroundACR, ESUR and AdMeTech Foundation. Prostate Imaging Reporting & Data System (PI-RADS). 2019. Version 2.1.
- Background: PubMed 23606141Hegde JV, Mulkern RV, Panych LP, Fennessy FM, Fedorov A, Maier SE, Tempany CM. Multiparametric MRI of prostate cancer: an update on state-of-the-art techniques and their performance in detecting and localizing prostate cancer. J Magn Reson Imaging. 2013 May;37(5):1035-54. doi: 10.1002/jmri.23860.
- Background: PubMed 37750774Bischoff LM, Peeters JM, Weinhold L, Krausewitz P, Ellinger J, Katemann C, Isaak A, Weber OM, Kuetting D, Attenberger U, Pieper CC, Sprinkart AM, Luetkens JA. Deep Learning Super-Resolution Reconstruction for Fast and Motion-Robust T2-weighted Prostate MRI. Radiology. 2023 Sep;308(3):e230427. doi: 10.1148/radiol.230427.
- Background: PubMed 36070533Bischoff LM, Katemann C, Isaak A, Mesropyan N, Wichtmann B, Kravchenko D, Endler C, Kuetting D, Pieper CC, Ellinger J, Weber O, Attenberger U, Luetkens JA. T2 Turbo Spin Echo With Compressed Sensing and Propeller Acquisition (Sampling k-Space by Utilizing Rotating Blades) for Fast and Motion Robust Prostate MRI: Comparison With Conventional Acquisition. Invest Radiol. 2023 Mar 1;58(3):209-215. doi: 10.1097/RLI.0000000000000923. Epub 2022 Sep 2.
- Background: PubMed 29077588Weiss J, Martirosian P, Notohamiprodjo M, Kaufmann S, Othman AE, Grosse U, Nikolaou K, Gatidis S. Implementation of a 5-Minute Magnetic Resonance Imaging Screening Protocol for Prostate Cancer in Men With Elevated Prostate-Specific Antigen Before Biopsy. Invest Radiol. 2018 Mar;53(3):186-190. doi: 10.1097/RLI.0000000000000427.
- Background: PubMed 28314291Scialpi M, Prosperi E, D'Andrea A, Martorana E, Malaspina C, Palumbo B, Orlandi A, Falcone G, Milizia M, Mearini L, Aisa MC, Scialpi P, DE Dominicis C, Bianchi G, Sidoni A. Biparametric versus Multiparametric MRI with Non-endorectal Coil at 3T in the Detection and Localization of Prostate Cancer. Anticancer Res. 2017 Mar;37(3):1263-1271. doi: 10.21873/anticanres.11443.
- Background: PubMed 24447678Rais-Bahrami S, Siddiqui MM, Vourganti S, Turkbey B, Rastinehad AR, Stamatakis L, Truong H, Walton-Diaz A, Hoang AN, Nix JW, Merino MJ, Wood BJ, Simon RM, Choyke PL, Pinto PA. Diagnostic value of biparametric magnetic resonance imaging (MRI) as an adjunct to prostate-specific antigen (PSA)-based detection of prostate cancer in men without prior biopsies. BJU Int. 2015 Mar;115(3):381-8. doi: 10.1111/bju.12639. Epub 2014 Sep 15.
- Background: PubMed 27726850De Visschere P, Lumen N, Ost P, Decaestecker K, Pattyn E, Villeirs G. Dynamic contrast-enhanced imaging has limited added value over T2-weighted imaging and diffusion-weighted imaging when using PI-RADSv2 for diagnosis of clinically significant prostate cancer in patients with elevated PSA. Clin Radiol. 2017 Jan;72(1):23-32. doi: 10.1016/j.crad.2016.09.011. Epub 2016 Oct 7.
- Background: PubMed 34464739Huang SY, Witzel T, Keil B, Scholz A, Davids M, Dietz P, Rummert E, Ramb R, Kirsch JE, Yendiki A, Fan Q, Tian Q, Ramos-Llorden G, Lee HH, Nummenmaa A, Bilgic B, Setsompop K, Wang F, Avram AV, Komlosh M, Benjamini D, Magdoom KN, Pathak S, Schneider W, Novikov DS, Fieremans E, Tounekti S, Mekkaoui C, Augustinack J, Berger D, Shapson-Coe A, Lichtman J, Basser PJ, Wald LL, Rosen BR. Connectome 2.0: Developing the next-generation ultra-high gradient strength human MRI scanner for bridging studies of the micro-, meso- and macro-connectome. Neuroimage. 2021 Nov;243:118530. doi: 10.1016/j.neuroimage.2021.118530. Epub 2021 Aug 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian A Luetkens, PD Dr. med principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of PI-RADS scores (time frame: January - February 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244680, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.