Prostate CancerNCT04962269
Application of DWI in Diagnosis of Prostate Cancer
An observational study of Prostate Cancer and Benign Prostatic Hyperplasia, run by Peking University Third Hospital.
Trial summary
This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Benign Prostatic Hyperplasia
- What is being tested?
- MRI
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2013to 21 Jun 2018
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with prostatic diseases confirmed as prostate cancer or benign prostatic hyperplasia
Who may be able to join
- The exam including T1WI、T2WI and multiple b-value DWI.
- Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam.
Who cannot join
- 1.No Gleason score data. 2.Awful quality of imagings or artifacts affectting diagnosis. 3.No lesion larger than 0.5cm. 4.Any surgery or treatment before MRI exam. 5.Biopsy in 4 weeks before MRI exam.
About this study
Official title: Different Models of Multiple B-value DWI and Their Applications in Diagnosis of Prostate Cancer
This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer.
Read the detailed description
Diffusion weighted imaging (DWI) plays an important role in the diagnosis and stratification of prostate cancer. Traditional DWI apply the apparent diffusion coefficient (ADC) to reflect the diffusion of tissue water, which is a parameter calculated by a monoexponential model with 2b values. In recent years, the development of multiple b-value DWI facilitates the appearance of many new mathematical models. Different models have different features, but their value of applications in prostate cancer still need to be confirmed. This study was aiming to: (1) compare the parameters derived from monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model between prostate cancer and benign prostatic hyperplasia; (2) compare the difference of these parameters between low-grade (Gleason score ≤ 3+4) and high-grade (Gleason score ≥ 4+3) cancer; (3) find whether these parameters derived from new models are superior to ADC derived from traditional monoexponetial model.
- Conditions
- Prostate Cancer, Benign Prostatic Hyperplasia
- Being tested
- MRI
- Keywords
- benign prostatic hyperplasia, Diffusion weighted imaging
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model
| Study group | Role | What they receive |
|---|---|---|
| prostate cancer | The patient was pathologically diagnosed with prostate cancer Receives: Diagnostic Test: MRI | |
| benign prostatic hyperplasia | The patient was pathologically diagnosed with benign prostatic hyperplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological diagnosis
prostate cancer or benign prostatic hyperplasia
Measured: 2013.10-2018.6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start12 Jun 2013
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyu Liu, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962269
- Sponsor's protocol ID
- M2019176
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Models of Multiple B-value DWI and Their Applications in Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04962269
- Acronym / sponsor ID
- M2019176
- Conditions
- Prostate Cancer, Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, Diffusion weighted imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 14 Jul 2021 (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.
This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer.
Detailed description
Diffusion weighted imaging (DWI) plays an important role in the diagnosis and stratification of prostate cancer. Traditional DWI apply the apparent diffusion coefficient (ADC) to reflect the diffusion of tissue water, which is a parameter calculated by a monoexponential model with 2b values. In recent years, the development of multiple b-value DWI facilitates the appearance of many new mathematical models. Different models have different features, but their value of applications in prostate cancer still need to be confirmed. This study was aiming to: (1) compare the parameters derived from monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model between prostate cancer and benign prostatic hyperplasia; (2) compare the difference of these parameters between low-grade (Gleason score ≤ 3+4) and high-grade (Gleason score ≥ 4+3) cancer; (3) find whether these parameters derived from new models are superior to ADC derived from traditional monoexponetial model.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prostate cancer | – | Diagnostic Test: MRIThe patient was pathologically diagnosed with prostate cancer |
| benign prostatic hyperplasia | – | –The patient was pathologically diagnosed with benign prostatic hyperplasia |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with prostatic diseases confirmed as prostate cancer or benign prostatic hyperplasia
Key inclusion criteria (2 listed)
- The exam including T1WI、T2WI and multiple b-value DWI.
- Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam.
Key exclusion criteria (1 listed)
- 1.No Gleason score data. 2.Awful quality of imagings or artifacts affectting diagnosis. 3.No lesion larger than 0.5cm. 4.Any surgery or treatment before MRI exam. 5.Biopsy in 4 weeks before MRI exam.
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 |
|---|---|---|
| MRImonoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model | Diagnostic test | prostate cancer |
Primary outcome
pathological diagnosis
Time frame: 2013.10-2018.6
prostate cancer or benign prostatic hyperplasia
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 14 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Jianyu Liu study director
Peking University
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Benign Prostatic Hyperplasia, run by Peking University Third Hospital.
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 2 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 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
pathological diagnosis (time frame: 2013.10-2018.6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2021.