FMISO-PET in Brain Tumors and SCS Effect

NCT01868906 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-08-24

No results posted yet for this study

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

Temozolomide

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01868906 on ClinicalTrials.gov