Trimodal Imaging Before Radiotherapy

NCT03897166 | Completed

• 1 other identifier: CHB 17.02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

In oncology, personalized medicine is progressing by providing increasingly tumor- and patient-specific care. Thus, medical imaging allows precise morphological and functional characterization of the tumor by volume measurements, used in particular in radiotherapy to define the macroscopic tumor volume (GTV), and radiomic measurements that correspond to a recent concept of extraction of textural parameters and/or tumor shape (tumor heterogeneity, tumor invasiveness...). Precise characterization of the patient is also possible by anthropometric measurements (measurements of total muscle mass, visceral adipose tissue mass...) which can be important predictive and prognostic factors and which are generally estimated more accurately in imaging than by using mathematical formulas. However, these measurements are partly dependent on the imaging acquisition mode (PET, CT or MRI). The volume measurements, and therefore the GTV, are thus different depending on the imaging used. Studying these differences is important because no single imaging technique encompasses all potential GTV regions but, on the other hand, a combination of anatomical and functional information could improve tumor delineation. Beyond this volume analysis, the extraction of radiomic characteristics seems very promising in radiotherapy with however many limitations to be overcome, linked in particular to the data acquisition mode. Concerning anthropometric measurements, CT and MRI have become essential techniques for precise anatomical quantification, particularly of lean mass, visceral adipose tissue or muscle mass, but automatic measurement techniques for these parameters have yet to be defined, particularly during CT or MRI acquisitions associated with PET for attenuation correction. To identify useful volume, radiomic and anthropometric characteristics, medical imaging thus requires prospective cohorts of patients with comparable cancer histologies and standardized images acquired by different modalities (e. g. PET, CT or MRI) during the pre-treatment assessment before similar treatments. The purpose of this study is to create a prospective cohort to study volume, radiomic and anthropometric characteristics by taking advantage of the recent installation of MRI in the medical imaging department of the Henri Becquerel Cancer Center (HBCC), Rouen, France, allowing PET/MRI to be performed and by taking advantage of the collaboration between the radiotherapy and medical imaging departments of the HBCC.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Difference of volumes estimated by geometric indices with the three techniques

  The volumes studied will be defined for each imaging modality individually and in combination, taking into account several modalities at the same time

  2 weeks

Secondary Outcomes (2)

• Determination of methods to measure radiomics parameters

  2 weeks

• quality of the MRI PET attenuation correction: differences in SUVmax, SUVpeak and SUVmean

  2 weeks

Study Arms (1)

Trimodality Imaging

EXPERIMENTAL

Positron Emission Tomography coupled with Computed Tomography computed coupled with Magnetic Resonance Imaging and whole-body Biphoton Absorptiometry

Device: Trimodality

Interventions

Trimodality DEVICE

Positron Emission Tomography coupled with Computed tomography and immediately followed by Magnetic Resonance Imaging

Trimodality Imaging

Eligibility Criteria

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

You may qualify if:

• Positron Emission Tomography before radiotherapy
• More than 18 years
• PS 0 to 1
• Signed Inform consent Form

You may not qualify if:

• Contraindication to Magnetic resonance Imaging
• More than 150 kgs
• Pregnancy or child bearing

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Pierre Decazes, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: April 1, 2019
• Study Start: January 15, 2019
• Primary Completion: August 13, 2021
• Study Completion: August 30, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)