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MagneThermoPro : Magnetic Resonance Thermography of Human Prostate (ThermoPro)

Primary Purpose

Prostate Cancer Diagnosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI thermometry
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer Diagnosis focused on measuring MRI, prostate, thermometry, laser, ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • CHU BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thermometry MRI

Arm Description

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

Outcomes

Primary Outcome Measures

signal noise ratio
the evaluation of the signal on the thermometry sequence

Secondary Outcome Measures

temperature variance
temperature variance measurements in a region of interest of the prostate
spatial distortion measurement
spatial distortion measurement

Full Information

First Posted
March 25, 2021
Last Updated
December 26, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04822272
Brief Title
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate
Acronym
ThermoPro
Official Title
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Diagnosis
Keywords
MRI, prostate, thermometry, laser, ablation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thermometry MRI
Arm Type
Experimental
Arm Description
MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
Intervention Type
Device
Intervention Name(s)
MRI thermometry
Intervention Description
MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
Primary Outcome Measure Information:
Title
signal noise ratio
Description
the evaluation of the signal on the thermometry sequence
Time Frame
End of MRI exam (hour 1)
Secondary Outcome Measure Information:
Title
temperature variance
Description
temperature variance measurements in a region of interest of the prostate
Time Frame
End of MRI exam (hour 1)
Title
spatial distortion measurement
Description
spatial distortion measurement
Time Frame
End of MRI exam (hour 1)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clement Marcelin, MD
Phone
+335 56 79 55 99
Email
clement.marcelin@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Quesson, PhD
Email
bruno.quesson@u-bordeaux.fr
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement Marcelin, MD
Phone
+335 56 79 55 99
Email
clement.marcelin@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

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