MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

Prostate Cancer Diagnosis Clinical Trial

— ThermoPro  

Official title:

MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822272
• Other study ID #: CHUBX 2021/02
• Status: Completed
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Diagnosis
• Prostatic Neoplasms

Intervention

Device:
• MRI thermometry
MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	signal noise ratio	the evaluation of the signal on the thermometry sequence	End of MRI exam (hour 1)
Secondary	temperature variance	temperature variance measurements in a region of interest of the prostate	End of MRI exam (hour 1)
Secondary	spatial distortion measurement	spatial distortion measurement	End of MRI exam (hour 1)