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

Glioblastoma Multiforme Clinical Trial

— IMAGG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03370926
• Other study ID #: IMAGG
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 7, 2017
• Start date: October 31, 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2017
• Source: University Hospital, Brest
• Contact: Ulrick SCHICK
• Email: ulrike.schick[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Astrocytoma
• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Radiotherapy

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sites of failures with composite and standard MRI based RT planning	Irradiation target volumes associated with standard MRI based RT planning	12 months
Secondary	Progression-free Survival		12 months