FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy (IMAGG)

(18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy

Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema.

To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.

Study Overview

• Status: Unknown
• Conditions: Glioblastoma Multiforme; Anaplastic Astrocytoma; Radiotherapy

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Ulrick SCHICK; Email: ulrike.schick@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients diagnosed with anaplastic astrocytoma or glioblastoma who are referred for adjuvant radiotherapy.

Description

Inclusion Criteria:

• 18 Years or older
• Histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma
• Patients must have undergone surgery with macroscopic complete resection or incomplete resection with residual disease less than 5 cm on MRI
• An MRI or a scan 48h after surgery should be available
• WHO ≤ 2
• Indication for adjuvant radiotherapy
• Surgery must have been performed 45 days before the start of radiotherapy.
• Ability to understand and to give consent

Exclusion Criteria:

• Age < 18 Years.
• Prior radiation therapy to the brain
• Any usual formal indication against MRI (claustrophobia, metallic objects or implanted medical devices in body: pacemaker, clips, prostheses ...)
• Allergic reaction to FET
• Pregnant women or nursing mothers
• Refusal to use effective contraception at study entry and throughout the study if patient is of childbearing age.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images	Increase in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET.	Irradiation target volumes associated with standard MRI	12 months
Sites of failures with composite and standard MRI based RT planning	Irradiation target volumes associated with standard MRI based RT planning	12 months
Progression-free Survival		12 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

General Publications

• Dissaux B, Mazouz Fatmi D, Ognard J, Allard B, Keromnes N, Latreche A, Lepeuve A, Schick U, Bourbonne V, Ben Salem D, Dissaux G, Querellou S. Radiotherapy Target Volume Definition in Newly Diagnosed High-Grade Glioma Using 18F-FET PET Imaging and Multiparametric MRI: An Inter Observer Agreement Study. Tomography. 2022 Aug 16;8(4):2030-2041. doi: 10.3390/tomography8040170.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): October 31, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Astrocytoma
• Other Study ID Numbers: IMAGG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No