PRIS: Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Completed

CT.gov ID

NCT04704804

Collaborator

(none)

Enrollment

Location

11.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In radiotherapy, Magnetic Resonance Imaging (MRI) is used as a complement to the CT scanner because it provides better tissue contrast and therefore more precise delineations without the need for additional irradiation. However, MRI does not allow the definition of the electronic densities of the tissues necessary for dose calculation.

In this work, we sought to measure the feasibility of a method for generating CT-synthetic images from MRI in terms of dosimetric and geometrical precision for the purpose of MRI workflow alone (see diagram). The cerebral sphere and the prostate are the two tumor locations considered. All patients will have a planning CT (reference) and an MRI in the treatment position. The contours of the structures will be contoured by a radiotherapist on both the MRI and the reference CT. Synthetic CTs will be generated from the MRI with the method of automatic assignment of densities in five classes. The volumes bypassed and the dosimetries performed will be compared. A study of the quality of the images generated from MRI for dose calculation and images for the verification of per-treatment positioning will be performed.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Brain Cancer	Diagnostic Test: Synthetic CT Scan

Detailed Description

This is a prospective single-center dosimetry study that exhaustively included brain tumor and prostate cancer patients treated at the ICO Site d'Angers by external radiotherapy and prior to which they were given an MRI and a simulation CT in treatment position over a 12-month period.

For patients who agree to participate in the study, CT-synthetic images will be generated from the MRI images by automatic assignment of densities (5 classes).

Reference CT images from CT and synthetic CT images from MRI will be available for comparison for all eligible patients.

Study Design

Study Type:

Observational

Actual Enrollment :

94 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Feasibility of MRI Workflow Alone in External Radiotherapy for the Treatment of Brain and Prostate Tumors

Actual Study Start Date :

Jul 24, 2020

Actual Primary Completion Date :

Jul 15, 2021

Actual Study Completion Date :

Jul 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Prostate cancer Man with cancer and localized (non-metastatic) prostate cancer	Diagnostic Test: Synthetic CT Scan method of generating CT-synthetic image from MRI
Brain cancer Male or Female with a brain tumor (primitive)	Diagnostic Test: Synthetic CT Scan method of generating CT-synthetic image from MRI

Arm

Intervention/Treatment

Prostate cancer

Man with cancer and localized (non-metastatic) prostate cancer

Diagnostic Test: Synthetic CT Scan

method of generating CT-synthetic image from MRI

Brain cancer

Male or Female with a brain tumor (primitive)

Diagnostic Test: Synthetic CT Scan

method of generating CT-synthetic image from MRI

Outcome Measures

Primary Outcome Measures

describe the differences in volumetric and dosimetric accuracy between potential planning from MRI alone by CT-synthetics generation and standard planning from CT [3 month]
Comparison of the contours of target volumes and organs at risk and comparison of dose distributions (dosimetries)

Secondary Outcome Measures

Measurement of the quality of images generated from MRI for dose calculation and images for verification of per-treatment positioning relative to the reference CT in an MRI-only workflow objective. [3 month]
Comparison of CT-synthetic CT images generated from MRI to the reference CT and Comparison of shifts performed during patient repositioning

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years old
Male or Female with a (primary) brain tumour or Male with cancer and localized (non-metastatic) prostate cancer
Patient having benefited from a planning MRI scan in treatment position performed according to the new acquisition modalities (allowing the generation of CT-synthetics by automatic assignment of densities) performed since January 2020 and a planning scanner in treatment position prior to external radiotherapy.
Good general condition (SP < 3)

Exclusion Criteria:

Excluded forms of the disease,
MRI-specific contraindications (claustrophobia, foreign bodies)
Obesity preventing the placement of equipment (contention/antennae)
Poor general condition (SP > or = 2) preventing the patient from standing on the table

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancerologie de L'Ouest	Angers		France	49055

Sponsors and Collaborators

Institut Cancerologie de l'Ouest

Investigators

Principal Investigator: Damien AUTRET, INSTITUT DE CANCEROLOGIE DE L'OUEST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Cancerologie de l'Ouest

ClinicalTrials.gov Identifier:

NCT04704804

Other Study ID Numbers:

ICO-2020-09

First Posted:

Jan 12, 2021

Last Update Posted:

Mar 11, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Brain Neoplasms

Study Results

No Results Posted as of Mar 11, 2022