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

NCT04704804 | Completed

• 1 other identifier: ICO-2020-09
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Brain Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Prostate cancer

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

Diagnostic Test: Synthetic CT Scan

Brain cancer

Male or Female with a brain tumor (primitive)

Diagnostic Test: Synthetic CT Scan

Interventions

Synthetic CT Scan DIAGNOSTIC_TEST

method of generating CT-synthetic image from MRI

Brain cancer; Prostate cancer

Eligibility Criteria

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

Study Population

Patient with prostate or brain cancer receiving an MRI in addition to the simulated CT scan prior to the start of their external radiotherapy treatment

You may qualify if:

• 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)

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Brain 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; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Damien AUTRET

  INSTITUT DE CANCEROLOGIE DE L'OUEST

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: July 24, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)