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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Multiforme Anaplastic Astrocytoma Radiotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ulrick SCHICK

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ulrike SCHICK

Role: primary

References

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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.

Reference Type DERIVED

PMID: 36006068 (View on PubMed)

Other Identifiers

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IMAGG

Identifier Type: -

Identifier Source: org_study_id