MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

University Hospital of Bordeaux

Status: Completed

Conditions: Prostate Cancer Diagnosis

Treatments: Device: MRI thermometry

Study type: Interventional

Funder types: Other

Identifiers

NCT04822272

CHUBX 2021/02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 70 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Thermometry MRI

Experimental group

Description:

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

Treatment:

Device: MRI thermometry