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This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy.
The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-parametric MRI for Prostate Cancer | Experimental | MRI will be acquired for prostate cancer patients undergoing radiation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiparametric MRI | Device | MRI will be acquired before, during and after radiation treatment to evaluate treatment response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response | Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control. | 2 years |
| Tumor Response | Tumor response as measured by an increase in PSA. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-parametric MRI for Prostate Cancer | MRI will be acquired for prostate cancer patients undergoing radiation treatment. Multiparametric MRI: MRI will be acquired before, during and after radiation treatment to evaluate treatment response |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi-parametric MRI for Prostate Cancer | MRI will be acquired for prostate cancer patients undergoing radiation treatment. Multiparametric MRI: MRI will be acquired before, during and after radiation treatment to evaluate treatment response |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response | Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control. | Radiomics requires sufficient patient number. Not enough patients were included for radiomics analyses. PI left institution and country. The data was not collected so analysis could not be completed. | Posted | 2 years |
|
2 years
Only images of patients were acquired. There is no risk to the patients.
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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 | Multi-parametric MRI for Prostate Cancer | MRI will be acquired for prostate cancer patients undergoing radiation treatment. Multiparametric MRI: MRI will be acquired before, during and after radiation treatment to evaluate treatment response |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Brown | Henry Ford Health | 3135858415 | sbrown1@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2023 | May 11, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2023 | Jul 13, 2023 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2017 | Feb 28, 2023 | 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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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Tumor Response | Tumor response as measured by an increase in PSA. | The patient number was too small for the planned radiomics analysis. The study was closed. The data was not collected so analysis could not be completed. PI left institution and country. Analysis could not be completed. | Posted | 2 years |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003933 | Diagnosis |