Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trimodal Imaging Before Radiotherapy (TRIMODAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897166
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

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.


Condition or disease Intervention/treatment Phase
Cancer Device: Trimodality Not Applicable

Detailed Description:

The purpose of this study is to create a prospective cohort to study volume, radiomic and anthropometric characteristics. For that 60 patients will be included before treatment by radiotherapy.

Patients will benefit from a detailed pre-therapeutic imaging assessment with trimodal acquisitions (CT/MRI/PET with 18F-FDG) before radiotherapy and in radiotherapeutic position according to the "CRAI" (for "Centre Régional de thérapie Assistée par l'Imagerie") acquisition protocol, innovative in trimodality.

This initial imaging assessment will be supplemented by a whole-body biphoton absorptiometry which will be used as a reference examination for certain anthropometric parameters. This examination will be carried out at the Rouen University Hospital in the Rheumatology Department


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Volumetric, Radiomic and Anthropometric Characteristics in Trimodal Imaging (Positron Emission Tomography, Computed Tomography, Magnetic Resonance Imaging) Before Radiotherapy
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trimodality Imaging
Positron Emission Tomography coupled with Computed Tomography computed coupled with Magnetic Resonance Imaging and whole-body Biphoton Absorptiometry
Device: Trimodality
Positron Emission Tomography coupled with Computed tomography and immediately followed by Magnetic Resonance Imaging




Primary Outcome Measures :
  1. Difference of volumes estimated by geometric indices with the three techniques [ Time Frame: 2 weeks ]
    The volumes studied will be defined for each imaging modality individually and in combination, taking into account several modalities at the same time


Secondary Outcome Measures :
  1. Determination of methods to measure radiomics parameters [ Time Frame: 2 weeks ]
    the comparison of the different parameters obtained with a study of intra-modality and inter-modality correlations with algorithm to compare trimodality with the reference techniques

  2. quality of the MRI PET attenuation correction: differences in SUVmax, SUVpeak and SUVmean [ Time Frame: 2 weeks ]
    the calculation of differences in SUVmax, SUVpeak and SUVmean



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897166


Contacts
Layout table for location contacts
Contact: Pierre Decazes, MD +33276673059 pierre.decazes@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr

Locations
Layout table for location information
France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Pierre Decazes, Md    +3376673059    pierre.decazes@chb.unicancer.fr   
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Layout table for investigator information
Principal Investigator: Pierre Decazes, MD Centre Henri Becquerel

Layout table for additonal information
Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT03897166     History of Changes
Other Study ID Numbers: CHB 17.02
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No