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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. Identifier: NCT03897166
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Information provided by (Responsible Party):
Centre Henri Becquerel

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Trimodal Imaging Before Radiotherapy
Official Title  ICMJE Study of Volumetric, Radiomic and Anthropometric Characteristics in Trimodal Imaging (Positron Emission Tomography, Computed Tomography, Magnetic Resonance Imaging) Before Radiotherapy
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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cancer
Intervention  ICMJE Device: Trimodality
Positron Emission Tomography coupled with Computed tomography and immediately followed by Magnetic Resonance Imaging
Study Arms  ICMJE Experimental: Trimodality Imaging
Positron Emission Tomography coupled with Computed Tomography computed coupled with Magnetic Resonance Imaging and whole-body Biphoton Absorptiometry
Intervention: Device: Trimodality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2021
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pierre Decazes, MD +33276673059
Contact: Doriane Richard, PhD +33232082985
Listed Location Countries  ICMJE France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03897166
Other Study ID Numbers  ICMJE CHB 17.02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Henri Becquerel
Study Sponsor  ICMJE Centre Henri Becquerel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre Decazes, MD Centre Henri Becquerel
PRS Account Centre Henri Becquerel
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP