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

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Vincent BOURBONNE, MD, PhD; Phone Number: +33298223398; Email: vincent.bourbonne@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU Brest
    • Contact: Vincent BOURBONNE, MD, PhD; Phone Number: +33298223398; Email: vincent.bourbonne@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient treated or being treated for prostatic adenocarcinoma

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Assessing inter-sequence reproducibility	Assessing inter-sequence reproducibility	through study completion, an average of 6 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Vincent BOURBONNE, MD, PhD, Radiation Oncology Department, Brest University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MRI; radiotherapy; segmentation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 29BRC23.0145 - VARIOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No