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The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic MRI | Procedure | Participants will be scanned using a standard clinical prostate MRI protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of HM-MRI | The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI. | 12 months |
| Area Under the ROC Curve (AUC) of HM-MRI | In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of HM-MRI | Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy. | 12 months |
| Specificity of HM-MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aytekin Oto, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39836080 | Derived | Chatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156. |
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112 patients were screened and 6 patients did not meet eligibility criteria of the study.
106 patients were enrolled in the study. Patients were recruited based on physician referral at UChicago Medical Center. The 1st patient was enrolled on August 28, 2018, and the last patient was enrolled on March 29, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Arm | Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors. Diagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol. Diagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment. Risk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Arm | Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors. Diagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol. Diagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment. Risk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of HM-MRI | The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Arm | Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors. Diagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol. Diagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment. Risk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aytekin Oto, MD, MBA | Department of Radiology, University of Chicago | 1-773-702-8553 | aoto@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2022 | May 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2024 | May 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Diagnostic Prostate Biopsy | Procedure | Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment. |
|
| Risk Map DSS tool | Device | The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied. |
|
Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy. |
| 12 months |
| Positive Predictive Value (PPV) of HM-MRI | Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI. | 12 months |
| Negative Predictive Value (NPV) of HM-MRI | Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI. | 12 months |
| did not undergo biopsy |
|
| scanner problem |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Prostate Specific Antigen (PSA) | Mean | Standard Deviation | ng/mL |
|
| Units | Counts |
|---|---|
| Participants |
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|
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| Primary | Area Under the ROC Curve (AUC) of HM-MRI | In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1. | Posted | Mean | 95% Confidence Interval | probability | 12 months |
|
|
|
|
| Secondary | Sensitivity of HM-MRI | Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
|
|
|
| Secondary | Specificity of HM-MRI | Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
|
|
|
| Secondary | Positive Predictive Value (PPV) of HM-MRI | Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
|
|
|
|
| Secondary | Negative Predictive Value (NPV) of HM-MRI | Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 months |
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| 0 |
| 106 |
| 0 |
| 106 |
| 0 |
| 106 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |