NCT04822272

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

March 25, 2021

Last Update Submit

December 29, 2023

Conditions

Prostate Cancer Diagnosis

Keywords

MRIprostatethermometrylaserablation

Outcome Measures

Primary Outcomes (1)

  • signal noise ratio

    the evaluation of the signal on the thermometry sequence

    End of MRI exam (hour 1)

Secondary Outcomes (2)

  • temperature variance

    End of MRI exam (hour 1)

  • spatial distortion measurement

    End of MRI exam (hour 1)

Study Arms (1)

Thermometry MRI

EXPERIMENTAL

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

Device: MRI thermometry

Interventions

MRI thermometryDEVICE

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

Thermometry MRI

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • MRI contraindications (Pace Maker, metallic foreign body, metallic heart valve).
  • Contraindication to gadolinium salt,
  • Patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

July 8, 2022

Primary Completion

June 8, 2023

Study Completion

June 8, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)