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Completed

NCT Number: NCT04822272

MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI thermometry

Device

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

Primary outcomes

  1. signal noise ratio

    Time frame: End of MRI exam (hour 1)

    the evaluation of the signal on the thermometry sequence

Secondary outcomes

  1. temperature variance

    Time frame: End of MRI exam (hour 1)

    temperature variance measurements in a region of interest of the prostate

  2. spatial distortion measurement

    Time frame: End of MRI exam (hour 1)

    spatial distortion measurement

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ThermoPro

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2021
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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