Inter-observer Variability in the Segmentation of Prostat... | NCT05996289

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

NCT05996289

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Aug 18, 2023Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Aug 1, 2023

First Submission Date that Met QC Criteria

Aug 16, 2023

First Posted Date

Aug 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2023

Last Update Posted Date

Aug 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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 (\

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient treated or being treated for prostatic adenocarcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincent BOURBONNE, MD, PhD	Contact	+33298223398		vincent.bourbonne@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Vincent Bourbonne, MD, PhD	Radiation Oncology Department, Brest University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Brest	Recruiting	Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided