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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00009498 | Other Identifier | University of Michigan Medical IRB |
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This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diffusion MRI Assessment | Experimental | Men with newly diagnosed metastatic disease initiating therapy with androgen deprivation, or men with hormone refractory prostate cancer initiating treatment with chemotherapy, will be assessed by diffusion MRI (Magnetic Resonance Imaging) at baseline, 2 weeks and again at 9-12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion MRI | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in diffusion MRI measurements | Identify changes in Diffusion Magnetic Resonance Imaging (MRI) measurements and correlate the changes with response to therapy. | Baseline, 2 weeks and 9-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in units/L of CK18Asp306 | Levels of CK18Asp396 can be measured in serum using a commercially available ELISA (Enzyme-linked Immunosorbent Assay). Changes in serum CK18Asp396 (a marker of apoptosis) will be correlated with functional diffusion maps and treatment response. | Baseline, 2 weeks and 9-12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maha Hussain, MD, FACP | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25859981 | Derived | Brisset JC, Hoff BA, Chenevert TL, Jacobson JA, Boes JL, Galban S, Rehemtulla A, Johnson TD, Pienta KJ, Galban CJ, Meyer CR, Schakel T, Nicolay K, Alva AS, Hussain M, Ross BD. Integrated multimodal imaging of dynamic bone-tumor alterations associated with metastatic prostate cancer. PLoS One. 2015 Apr 10;10(4):e0123877. doi: 10.1371/journal.pone.0123877. eCollection 2015. |
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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 |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Change in levels of bone turnover markers |
Correlate the changes in biochemical markers of bone turnover, such as N-telopeptide and bone-specific alkaline phosphatase, with functional diffusion maps and treatment response. |
| Baseline, 2 weeks and 9-12 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D038524 |
| Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |