NCT03897166: TRIMODAL

Trimodal Imaging Before Radiotherapy

Completed NA Last updated 3 May 2023

What this trial tests

NA trial testing Trimodality in Cancer in 56 participants. Completed in 30 August 2021.

Timeline

15 January 2019

Primary endpoint
13 August 2021

30 August 2021

Quick facts

Lead sponsor	Centre Henri Becquerel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	56
Start date	15 January 2019
Primary completion	13 August 2021
Estimated completion	30 August 2021
Sites	1 location across France

Drugs / interventions tested

• Trimodality

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Centre Henri Becquerel — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trimodality PET/CT/MRI and Radiotherapy: A Mini-Review.
   Decazes P, Hinault P, Veresezan O, Thureau S, et al · · 2020 · cited 29× · PMID 33614497 · DOI 10.3389/fonc.2020.614008
2. Characterization of positioning uncertainties in PET-CT-MR trimodality solutions for radiotherapy.
   Hinault P, Gardin I, Gouel P, Decazes P, et al · · 2022 · cited 1× · PMID 35481611 · DOI 10.1002/acm2.13617