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FMISO-PET in Brain Tumors and SCS Effect

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01868906
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bernardino Clavo, MD, PhD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bernardino Clavo, MD, PhDBernardino Clavo, MD, PhDFrancisco Robaina, MD, PhDJuan C Alonso, MD, PhD
Principal Investigator Affiliation	Dr. Negrin University Hospital, Las PalmasDr. Negrin University Hospital, Las PalmasDr. Negrin University Hospital, Las PalmasInstituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Terminated
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Glioma

Additional Details

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).

Arms & Interventions

Arms

Other: Arm-A: 18F-FMISO-PET without SCS

One 18F-FMISO-PET study for assessment of tumor hypoxia before radiotherapy and Temozolomide, without spinal cord stimulation.

Other: Arm-B: 18F-FMISO-PET without/with SCS

Two 18F-FMISO-PET studies for assessment of tumor hypoxia before radiotherapy and Temozolomide: one "without" and one "with" spinal cord stimulation

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Dr. Negrin University Hospital, Las Palmas, Spain

Status

Address

Dr. Negrin University Hospital

Las Palmas, , 35010

Madrid, Spain