FMISO-PET in Brain Tumors and SCS Effect

• Status: Terminated
• Trial end date: 2017-09-17
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess, with 18F-FMISO PET, hypoxia in high grade gliomas and changes by spinal cord stimulation in a subset of patients. Additionally, the potential correlation with pathological, imaging and clinical parameters will be analyzed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bernardino Clavo, MD, PhD
• Collaborators: Fundación DISA, Canary Islands, Spain; Grupo de Investigación Clínica en Oncología Radioterapia; Instituto Canario de Investigación del Cáncer; Instituto de Salud Carlos III; Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid; RSbiomed
• Treatments: Dacarbazine; Misonidazole; Temozolomide

Criteria

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.