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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03370926
Acronym
IMAGG
Enrollment
30
Registered
2017-12-13
Start date
2016-10-31
Completion date
2019-10-31
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaplastic Astrocytoma, Glioblastoma Multiforme, Radiotherapy

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images12 monthsIncrease in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique.

Secondary

MeasureTime frameDescription
Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET.12 monthsIrradiation target volumes associated with standard MRI
Sites of failures with composite and standard MRI based RT planning12 monthsIrradiation target volumes associated with standard MRI based RT planning
Progression-free Survival12 months

Countries

France

Contacts

Primary ContactUlrick SCHICK
ulrike.schick@chu-brest.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026