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

Prostate Cancer Clinical Trial

— PRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704804
• Other study ID #: ICO-2020-09
• Status: Completed
• Start date: July 24, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: March 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old

2. Male or Female with a (primary) brain tumour or Male with cancer and localized (non-metastatic) prostate cancer

3. 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.

4. Good general condition (SP < 3)

Exclusion Criteria:

1. Excluded forms of the disease,

2. MRI-specific contraindications (claustrophobia, foreign bodies)

3. Obesity preventing the placement of equipment (contention/antennae)

4. Poor general condition (SP > or = 2) preventing the patient from standing on the table -

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Synthetic CT Scan
method of generating CT-synthetic image from MRI

Locations

Country	Name	City	State
France	Institut de Cancerologie de L'Ouest	Angers

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	describe the differences in volumetric and dosimetric accuracy between potential planning from MRI alone by CT-synthetics generation and standard planning from CT	Comparison of the contours of target volumes and organs at risk and comparison of dose distributions (dosimetries)	3 month
Secondary	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.	Comparison of CT-synthetic CT images generated from MRI to the reference CT and Comparison of shifts performed during patient repositioning	3 month