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Trial Title:
Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)
NCT ID:
NCT05996289
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
radiotherapy
MRI
segmentation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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:
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
Criteria for eligibility:
Study pop:
Patient treated or being treated for prostatic adenocarcinoma
Sampling method:
Non-Probability Sample
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 (
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Brest
Address:
City:
Brest
Zip:
29609
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent Bourbonne, MD, PhD
Phone:
+33298223398
Email:
vincent.bourbonne@chu-brest.fr
Start date:
August 1, 2023
Completion date:
July 1, 2024
Lead sponsor:
Agency:
University Hospital, Brest
Agency class:
Other
Source:
University Hospital, Brest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996289
