Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial
<div><p>Background</p><p>Magnetic resonance imaging (MRI) combined with targeted biopsy (TB) is increasingly used in men with clinically suspected prostate cancer (PCa), but the long acquisition times, high costs, and inter-center/reader variability of routine multiparametric...
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| مؤلفون آخرون: | , , , , , , , , , , , , , , , , , , , , |
| منشور في: |
2019
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| _version_ | 1855411970084175872 |
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| author | Ivan Jambor (5701865) |
| author2 | Janne Verho (6791438) Otto Ettala (6791441) Juha Knaapila (6791444) Pekka Taimen (773545) Kari T. Syvänen (6791447) Aida Kiviniemi (835995) Esa Kähkönen (807207) Ileana Montoya Perez (2659849) Marjo Seppänen (6791450) Antti Rannikko (4720587) Outi Oksanen (6791453) Jarno Riikonen (6791456) Sanna Mari Vimpeli (6791459) Tommi Kauko (773546) Harri Merisaari (6791462) Markku Kallajoki (114542) Tuomas Mirtti (155123) Tarja Lamminen (6791465) Jani Saunavaara (6791468) Hannu J. Aronen (6791471) Peter J. Boström (470005) |
| author2_role | author author author author author author author author author author author author author author author author author author author author author |
| author_facet | Ivan Jambor (5701865) Janne Verho (6791438) Otto Ettala (6791441) Juha Knaapila (6791444) Pekka Taimen (773545) Kari T. Syvänen (6791447) Aida Kiviniemi (835995) Esa Kähkönen (807207) Ileana Montoya Perez (2659849) Marjo Seppänen (6791450) Antti Rannikko (4720587) Outi Oksanen (6791453) Jarno Riikonen (6791456) Sanna Mari Vimpeli (6791459) Tommi Kauko (773546) Harri Merisaari (6791462) Markku Kallajoki (114542) Tuomas Mirtti (155123) Tarja Lamminen (6791465) Jani Saunavaara (6791468) Hannu J. Aronen (6791471) Peter J. Boström (470005) |
| author_role | author |
| dc.creator.none.fl_str_mv | Ivan Jambor (5701865) Janne Verho (6791438) Otto Ettala (6791441) Juha Knaapila (6791444) Pekka Taimen (773545) Kari T. Syvänen (6791447) Aida Kiviniemi (835995) Esa Kähkönen (807207) Ileana Montoya Perez (2659849) Marjo Seppänen (6791450) Antti Rannikko (4720587) Outi Oksanen (6791453) Jarno Riikonen (6791456) Sanna Mari Vimpeli (6791459) Tommi Kauko (773546) Harri Merisaari (6791462) Markku Kallajoki (114542) Tuomas Mirtti (155123) Tarja Lamminen (6791465) Jani Saunavaara (6791468) Hannu J. Aronen (6791471) Peter J. Boström (470005) |
| dc.date.none.fl_str_mv | 2019-06-03T17:26:32Z |
| dc.identifier.none.fl_str_mv | 10.1371/journal.pmed.1002813 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/dataset/Validation_of_IMPROD_biparametric_MRI_in_men_with_clinically_suspected_prostate_cancer_A_prospective_multi-institutional_trial/8219267 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Medicine Cell Biology Pharmacology Biotechnology Developmental Biology Cancer Infectious Diseases Virology Space Science SPCa IMPROD bpMRI findings biopsy NPV Gleason grade group 2 PCa T 2-weighted imaging Trial registration ClinicalTrials.gov NCT 02241122 Conclusions IMPROD bpMRI suspicion CI IMPROD biparametric MRI SB prostate cancer multi-institutional trial Background TB multiparametric prostate MRI limit diffusion-weighed imaging acquisitions |
| dc.title.none.fl_str_mv | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| dc.type.none.fl_str_mv | Dataset info:eu-repo/semantics/publishedVersion dataset |
| description | <div><p>Background</p><p>Magnetic resonance imaging (MRI) combined with targeted biopsy (TB) is increasingly used in men with clinically suspected prostate cancer (PCa), but the long acquisition times, high costs, and inter-center/reader variability of routine multiparametric prostate MRI limit its wider adoption.</p><p>Methods and findings</p><p>The aim was to validate a previously developed unique MRI acquisition and reporting protocol, IMPROD biparametric MRI (bpMRI) (NCT01864135), in men with a clinical suspicion of PCa in a multi-institutional trial (NCT02241122). IMPROD bpMRI has average acquisition time of 15 minutes (no endorectal coil, no intravenous contrast use) and consists of T2-weighted imaging and 3 separate diffusion-weighed imaging acquisitions. Between February 1, 2015, and March 31, 2017, 364 men with a clinical suspicion of PCa were enrolled at 4 institutions in Finland. Men with an equivocal to high suspicion (IMPROD bpMRI Likert score 3–5) of PCa had 2 TBs of up to 2 lesions followed by a systematic biopsy (SB). Men with a low to very low suspicion (IMPROD bpMRI Likert score 1–2) had only SB. All data and protocols are freely available. The primary outcome of the trial was diagnostic accuracy—including overall accuracy, sensitivity, specificity, negative predictive value (NPV), and positive predictive value—of IMPROD bpMRI for clinically significant PCa (SPCa), which was defined as a Gleason score ≥ 3 + 4 (Gleason grade group 2 or higher). In total, 338 (338/364, 93%) prospectively enrolled men completed the trial. The accuracy and NPV of IMPROD bpMRI for SPCa were 70% (113/161) and 95% (71/75) (95% CI 87%–98%), respectively. Restricting the biopsy to men with equivocal to highly suspicious IMPROD bpMRI findings would have resulted in a 22% (75/338) reduction in the number of men undergoing biopsy while missing 4 (3%, 4/146) men with SPCa. The main limitation is uncertainty about the true PCa prevalence in the study cohort, since some of the men may have PCa despite having negative biopsy findings.</p><p>Conclusions</p><p>IMPROD bpMRI demonstrated a high NPV for SPCa in men with a clinical suspicion of PCa in this prospective multi-institutional clinical trial.</p><p>Trial registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT02241122" target="_blank">NCT02241122</a>.</p></div> |
| eu_rights_str_mv | openAccess |
| id | Manara_fe5c19bb2045237cffd9617cf53e7b9c |
| identifier_str_mv | 10.1371/journal.pmed.1002813 |
| network_acronym_str | Manara |
| network_name_str | ManaraRepo |
| oai_identifier_str | oai:figshare.com:article/8219267 |
| publishDate | 2019 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trialIvan Jambor (5701865)Janne Verho (6791438)Otto Ettala (6791441)Juha Knaapila (6791444)Pekka Taimen (773545)Kari T. Syvänen (6791447)Aida Kiviniemi (835995)Esa Kähkönen (807207)Ileana Montoya Perez (2659849)Marjo Seppänen (6791450)Antti Rannikko (4720587)Outi Oksanen (6791453)Jarno Riikonen (6791456)Sanna Mari Vimpeli (6791459)Tommi Kauko (773546)Harri Merisaari (6791462)Markku Kallajoki (114542)Tuomas Mirtti (155123)Tarja Lamminen (6791465)Jani Saunavaara (6791468)Hannu J. Aronen (6791471)Peter J. Boström (470005)MedicineCell BiologyPharmacologyBiotechnologyDevelopmental BiologyCancerInfectious DiseasesVirologySpace ScienceSPCaIMPROD bpMRI findingsbiopsyNPVGleason grade group 2PCaT 2-weighted imagingTrial registration ClinicalTrials.gov NCT 02241122Conclusions IMPROD bpMRIsuspicionCIIMPROD biparametric MRISBprostate cancermulti-institutional trial BackgroundTBmultiparametric prostate MRI limitdiffusion-weighed imaging acquisitions<div><p>Background</p><p>Magnetic resonance imaging (MRI) combined with targeted biopsy (TB) is increasingly used in men with clinically suspected prostate cancer (PCa), but the long acquisition times, high costs, and inter-center/reader variability of routine multiparametric prostate MRI limit its wider adoption.</p><p>Methods and findings</p><p>The aim was to validate a previously developed unique MRI acquisition and reporting protocol, IMPROD biparametric MRI (bpMRI) (NCT01864135), in men with a clinical suspicion of PCa in a multi-institutional trial (NCT02241122). IMPROD bpMRI has average acquisition time of 15 minutes (no endorectal coil, no intravenous contrast use) and consists of T2-weighted imaging and 3 separate diffusion-weighed imaging acquisitions. Between February 1, 2015, and March 31, 2017, 364 men with a clinical suspicion of PCa were enrolled at 4 institutions in Finland. Men with an equivocal to high suspicion (IMPROD bpMRI Likert score 3–5) of PCa had 2 TBs of up to 2 lesions followed by a systematic biopsy (SB). Men with a low to very low suspicion (IMPROD bpMRI Likert score 1–2) had only SB. All data and protocols are freely available. The primary outcome of the trial was diagnostic accuracy—including overall accuracy, sensitivity, specificity, negative predictive value (NPV), and positive predictive value—of IMPROD bpMRI for clinically significant PCa (SPCa), which was defined as a Gleason score ≥ 3 + 4 (Gleason grade group 2 or higher). In total, 338 (338/364, 93%) prospectively enrolled men completed the trial. The accuracy and NPV of IMPROD bpMRI for SPCa were 70% (113/161) and 95% (71/75) (95% CI 87%–98%), respectively. Restricting the biopsy to men with equivocal to highly suspicious IMPROD bpMRI findings would have resulted in a 22% (75/338) reduction in the number of men undergoing biopsy while missing 4 (3%, 4/146) men with SPCa. The main limitation is uncertainty about the true PCa prevalence in the study cohort, since some of the men may have PCa despite having negative biopsy findings.</p><p>Conclusions</p><p>IMPROD bpMRI demonstrated a high NPV for SPCa in men with a clinical suspicion of PCa in this prospective multi-institutional clinical trial.</p><p>Trial registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT02241122" target="_blank">NCT02241122</a>.</p></div>2019-06-03T17:26:32ZDatasetinfo:eu-repo/semantics/publishedVersiondataset10.1371/journal.pmed.1002813https://figshare.com/articles/dataset/Validation_of_IMPROD_biparametric_MRI_in_men_with_clinically_suspected_prostate_cancer_A_prospective_multi-institutional_trial/8219267CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/82192672019-06-03T17:26:32Z |
| spellingShingle | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial Ivan Jambor (5701865) Medicine Cell Biology Pharmacology Biotechnology Developmental Biology Cancer Infectious Diseases Virology Space Science SPCa IMPROD bpMRI findings biopsy NPV Gleason grade group 2 PCa T 2-weighted imaging Trial registration ClinicalTrials.gov NCT 02241122 Conclusions IMPROD bpMRI suspicion CI IMPROD biparametric MRI SB prostate cancer multi-institutional trial Background TB multiparametric prostate MRI limit diffusion-weighed imaging acquisitions |
| status_str | publishedVersion |
| title | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| title_full | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| title_fullStr | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| title_full_unstemmed | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| title_short | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| title_sort | Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial |
| topic | Medicine Cell Biology Pharmacology Biotechnology Developmental Biology Cancer Infectious Diseases Virology Space Science SPCa IMPROD bpMRI findings biopsy NPV Gleason grade group 2 PCa T 2-weighted imaging Trial registration ClinicalTrials.gov NCT 02241122 Conclusions IMPROD bpMRI suspicion CI IMPROD biparametric MRI SB prostate cancer multi-institutional trial Background TB multiparametric prostate MRI limit diffusion-weighed imaging acquisitions |