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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04822272
Other study ID # CHUBX 2021/02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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