Know Cancer

forgot password

Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation

Phase 2
18 Years
75 Years
Not Enrolling
Malignant Glioma

Thank you

Trial Information

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
concurrent radiochemotherapy).

Inclusion Criteria:

- Patients with pathologically confirmed (first presentation or relapsed) high grade
glioma (Grade III or Grade IV according WHO criteria) proposed for radical treatment
with 3D radiotherapy and temozolomide.

- Patients 18-75 years old.

- Karnofsky >= 60% and ECOG =< 2.

- Signed informed consent.

Exclusion Criteria:

- Clinical or psychological contraindications to fly (if 18F-FMISO-PET is realized in
Madrid) or to SCS-placement (only for this subset).

- Pregnant or breastfeeding women and women of fertile age who are not using a safe
contraceptive method or do not intend to use one during the trial. Safe contraceptive
methods are oral or parenteral contraceptive treatments or barrier methods: masculine
or feminine condom, diaphragm and/or intrauterine device (IUD) or withdrawal over the
course of the study.

- Serious co-existing or concurrent illness, including any of the following:
uncontrolled or severe infection, heart, liver or kidney disease

- Lung thromboembolism.

- Another malignancy in the last 5 years other than basal cell or squamous cell
carcinoma of the skin or carcinoma in situ of the cervix.

- Patients with life expectancy <3 months.

- Patients with any of the following: creatinine > 2 mg/dl, neutrophils <1.5 * 10^9/L,
platelets <100 * 10^9/L or hemoglobin <8.5 g/dL.

- Contraindications to receive radiotherapy or chemotherapy Clinical or psychological
contraindications for placement of spinal cord stimulation devices (only for that
specific subset of patients).

- Patients who are unable or unwilling to meet the protocol study.

- Patients who do not meet all the inclusion criteria.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumor hypoxia measurement using 18F-FMISO-PET (hypoxic volume and maximum tissue/blood ratio). Baseline measurement.

Outcome Description:

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.

Outcome Time Frame:

18F-FMISO-PET between 1 and 3 weeks before the commencement of radio-chemotherapy

Safety Issue:


Principal Investigator

Bernardino Clavo, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dr. Negrin University Hospital, Las Palmas


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

June 2013

Completion Date:

December 2016

Related Keywords:

  • Malignant Glioma
  • Anaplastic Astrocytoma
  • Brain Tumors
  • Cancer Imaging
  • Fluoromisonidazole
  • Glioblastoma
  • High Grade Glioma
  • Hypoxia Modification
  • Positron Emission Tomography
  • Radiation-Sensitizing Agents
  • Spinal Cord Stimulation
  • Tumor Hypoxia Measurement
  • Brain Neoplasms
  • Glioma