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

• Conditions: Glioblastoma Multiforme; Anaplastic Astrocytoma; Radiotherapy

• Registration Number: NCT03370926
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-10-31
• Status Verified: 2017-11
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France