Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation
Tumour ischaemia-hypoxia decreases the efficacy of radio-chemotherapy. Polarographic probe
(and some 18F-FMISO-PET) studies have demonstrated prognostic value. Additionally hypoxia
modification may increase survival. However, in high grade gliomas (HGG) there are not well
established methods to evaluate and modify tumor hypoxia. We have previously described how
spinal cord stimulation (SCS) can modify oxygenation, blood flow and metabolism in malignant
gliomas. The aim of this study is to assess with 18F-FMISO PET: hypoxia in HGG and changes
by spinal cord stimulation in a subset of patients. Additionally, the potential correlation
with pathological, imaging and clinical parameters will be analyzed.
18F-FMISO PET will be performed in 20 patients with diagnosis of HGG: after surgery/biopsy
and before radical treatment with 3D radiotherapy and temozolomide. A subset of 10 patients
undergo two studies with 18F- FMISO-PET (one with SCS "off" and one with SCS "on"). In these
patients, SCS will be connected from 1 hour before to 1 hour after each radiotherapy
session, and in the day-time during the days of adjuvant temozolomide.
18F-FMISO PET results will not be taking into account for patient management. Patients will
be followed at least until the end of adjuvant temozolomide (6 months after the end of
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Tumor hypoxia measurement using 18F-FMISO-PET (hypoxic volume and maximum tissue/blood ratio). Baseline measurement.
Tumor hypoxia will be measured in 20 patients with HGG using 18F-FMISO-PET: after biopsy or surgery and before the commencement of radio-chemotherapy. It will be assessed the prevalence and extent of significant hypoxia in HGG.
18F-FMISO-PET between 1 and 3 weeks before the commencement of radio-chemotherapy
Bernardino Clavo, MD, PhD
Dr. Negrin University Hospital, Las Palmas
Spain: Spanish Agency of Medicines