MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

Not Applicable

Completed

• Conditions: Prostate Cancer Diagnosis
• Interventions: Device: MRI thermometry

• Registration Number: NCT04822272
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-30
• Study Start: 2022-07-08
• Primary Completion: 2023-06-08
• Study Completion: 2023-06-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermometry MRI	MRI thermometry	MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

Primary Outcome Measures

Name	Time	Method
signal noise ratio	End of MRI exam (hour 1)	the evaluation of the signal on the thermometry sequence

Secondary Outcome Measures

Name	Time	Method
temperature variance	End of MRI exam (hour 1)	temperature variance measurements in a region of interest of the prostate
spatial distortion measurement	End of MRI exam (hour 1)	spatial distortion measurement

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France