FMISO-PET in Brain Tumors and SCS Effect
NCT01868906 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2018-08-24
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.
Conditions
- Malignant Glioma
Interventions
- DRUG
-
18F-FMISO
18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
- PROCEDURE
-
PET without SCS
PET-scanning using 18F-fluoromisonidazole without SCS
- DEVICE
-
SCS
Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.
- PROCEDURE
-
PET without/with SCS
Second PET-scanning using 18F-fluoromisonidazole: without/with SCS
- RADIATION
-
Radiotherapy
Standard radiation therapy
- DRUG
-
Standard treatment with concurrent and adjuvant Temozolomide.
Sponsors & Collaborators
-
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
collaborator UNKNOWN -
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Grupo de Investigación Clínica en Oncología Radioterapia
collaborator OTHER -
Instituto Canario de Investigación del Cáncer
collaborator OTHER -
RSbiomed
collaborator UNKNOWN -
Fundación DISA, Canary Islands, Spain
collaborator UNKNOWN -
Bernardino Clavo, MD, PhD
lead OTHER
Principal Investigators
-
Bernardino Clavo, MD, PhD · Dr. Negrin University Hospital, Las Palmas
-
Bernardino Clavo, MD, PhD · Dr. Negrin University Hospital, Las Palmas
-
Francisco Robaina, MD, PhD · Dr. Negrin University Hospital, Las Palmas
-
Juan C Alonso, MD, PhD · Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2017-09-17
- Completion
- 2017-09-17
Countries
- Spain
Study Locations
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