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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00155-36 | Other Identifier | ANSM |
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The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance
Prostate MRI has become the benchmark examination to search for tumor targets, thanks to a multi-parameter protocol, including T2 sequences, diffusions, and T1 with gadolinium injection. A PIRADS prognostic score is performed on the different sequences and if the lesions are at high risk of malignancy (PIRADS 4 and 5), a targeted biopsy is performed. Minimally invasive ablations called focal treatments are developing more and more: HIFU, cryotherapy, laser, etc. Ultrasound remains the most widespread examination due to its availability, but with less sensitivity than MRI. Ablations are performed under ultrasound with fusion of MRI images In order to assess the ablation area under MRI, the measurement of temperature variations appears necessary to verify the effectiveness of ablation and the lesion volume. Temperature maps are feasible in cardiac MRI during radiofrequency. The thermal mapping MRI sequence is performed in cardiac MRI at the IHU in Bordeaux.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermometry MRI | Experimental | MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI thermometry | Device | MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate |
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| Measure | Description | Time Frame |
|---|---|---|
| signal noise ratio | the evaluation of the signal on the thermometry sequence | End of MRI exam (hour 1) |
| Measure | Description | Time Frame |
|---|---|---|
| temperature variance | temperature variance measurements in a region of interest of the prostate | End of MRI exam (hour 1) |
| spatial distortion measurement | spatial distortion measurement |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France |
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MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
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| End of MRI exam (hour 1) |