MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2023-06-08

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

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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.

Conditions

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Prostate Cancer Diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Thermometry MRI

MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

Group Type EXPERIMENTAL

MRI thermometry

Intervention Type DEVICE

MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

Interventions

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MRI thermometry

MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No