Status:
TERMINATED
FMISO-PET in Brain Tumors and SCS Effect
Lead Sponsor:
Bernardino Clavo, MD, PhD
Collaborating Sponsors:
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Instituto de Salud Carlos III
Conditions:
Malignant Glioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 patho...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01868906
Start Date
June 1 2013
End Date
September 17 2017
Last Update
August 24 2018
Active Locations (2)
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1
Dr. Negrin University Hospital
Las Palmas, Spain, 35010
2
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Madrid, Spain, 28.033