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

NCT05996289 | Unknown

• 1 other identifier: 29BRC23.0145 - VARIOP
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

radiotherapy; MRI; segmentation

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Clinical factors influencing inter-observer variability.

  through study completion, an average of 6 months

• Assessing inter-sequence reproducibility

  through study completion, an average of 6 months

• Dosimetric impact of Inter-observer variability

  through study completion, an average of 6 months

Other Outcomes (1)

• Automatic segmentation of prostatic tumors

  through study completion, an average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient treated or being treated for prostatic adenocarcinoma

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Vincent Bourbonne, MD, PhD

  Radiation Oncology Department, Brest University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent BOURBONNE, MD, PhD

CONTACT

+33298223398; vincent.bourbonne@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 18, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

FR (1)