Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)

Prostate Cancer Clinical Trial

— VARIOP  

Official title:

Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996289
• Other study ID #: 29BRC23.0145 - VARIOP
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Brest
• Contact: Vincent BOURBONNE, MD, PhD
• Phone: +33298223398
• Email: vincent.bourbonne[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".

Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.

This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :

inter-operator contour variability

• Factors influencing contour

• Impact of contour variability on dosimetry

• Automatic segmentation

Description:

Following the major technological and scientific advances in external radiotherapy in recent decades, thanks to the use of three-dimensional conformal techniques combined with intensity modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without increasing sequelae and complications, giving rise to the term "dose escalation".

Following multiple dose-escalation clinical trials showing better biological control of PSA, the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost in relation to the primary prostate lesion, considered to be the preferred site of neoplastic recurrence in prostate cancer.

One of the issues raised by such a study is the methodology used to contour the tumour lesion, an issue which concerns the whole field of radiotherapy. The reference imaging technique for diagnosing prostate cancer, and more specifically the dominant tumour lesion, is multiparametric Magnetic Resonance Imaging. This leads to the first question, which concerns the identification of the dominant lesion and its precise delimitation. This last point is subject to variation between operators. A retrospective cohort from the Finistère region will therefore be used to develop a number of study points relating to :

inter-operator contour variability

• Factors influencing contour

• Impact of contour variability on dosimetry

• Automatic segmentation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Histologically proven localized prostatic neoplasia on trans-rectal biopsies.

• Multiparametric prostate MRI performed prior to prostate biopsies.

• No opposition expressed

• Patient affiliated to a social security scheme

Exclusion Criteria:

• History of surgery, prostatic irradiation or hormonal treatment prior to diagnosis.

• History of prostate cancer

• No identifiable target lesion on mpMRI (<PIRADS 3)

• Opposition formulated

• Patient under legal protection (guardianship, curatorship, etc.)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Chu Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Automatic segmentation of prostatic tumors	Contour variability using a deep-learning automated segmentation technique, with and without implementation of factors identified as impacting contour in manual technique.	through study completion, an average of 6 months
Primary	Inter-observer variability	The main criterion for judging inter-observer variability is the spatial overlap of contours on mpMRI, represented by the DICE similarity coefficient, which ranges from 0 to 1, where 1 represents zero variability between contours of the same lesion.	through study completion, an average of 6 months
Secondary	Clinical factors influencing inter-observer variability.	Subgroup analysis of radio-clinical-histological factors likely to influence inter-observer variability.	through study completion, an average of 6 months
Secondary	Assessing inter-sequence reproducibility	Assessing inter-sequence reproducibility	through study completion, an average of 6 months
Secondary	Dosimetric impact of Inter-observer variability	The influence of variability on dosimetry in IMRT/VMAT conformal radiotherapy.	through study completion, an average of 6 months