MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

Conditions
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Prostate Cancer Diagnosis

Intervention / Treatment
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* Device: MRI thermometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Patient with indication of injected multi-parameter MRI for the diagnosis of prostate cancer. Signed informed consent. Person affiliated or beneficiary of health insurance Exclusion Criteria: MRI contraindications (Pace Maker, metallic foreign body, metallic heart valve). Contraindication to gadolinium salt, Patient under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermometry MRI<br>MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate | Device: MRI thermometry<br>* MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| signal noise ratio | the evaluation of the signal on the thermometry sequence | End of MRI exam (hour 1) | 

Secondary Outcome Measures

| Outcome Measure | 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 | End of MRI exam (hour 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, prostate, thermometry, laser, ablation