MagneThermoPro : Magnetic Resonance Thermography of Human Prostate (ThermoPro)

December 29, 2023 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
signal noise ratio
Time Frame: End of MRI exam (hour 1)
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
Time Frame: End of MRI exam (hour 1)
temperature variance measurements in a region of interest of the prostate
End of MRI exam (hour 1)
spatial distortion measurement
Time Frame: End of MRI exam (hour 1)
spatial distortion measurement
End of MRI exam (hour 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2022

Primary Completion (Actual)

June 8, 2023

Study Completion (Actual)

June 8, 2023

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2021/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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