FMISO-PET in Brain Tumors and SCS Effect (FMISOPETSCS)

August 23, 2018 updated by: Bernardino Clavo, MD, PhD

Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Las Palmas, Spain, 35010
        • Dr. Negrin University Hospital
      • Madrid, Spain, 28.033
        • Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 18F-FMISO
18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
Other Names:
  • Fluoromisonidazole
  • FMISO
Procedure: PET without SCS
PET-scanning using 18F-fluoromisonidazole without SCS
Other Names:
  • Positron emission tomography scanning
Radiation: Radiotherapy
Standard radiation therapy
Other Names:
  • Radiation therapy
Drug: Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Other Names:
  • Temodar
  • Temodal
  • Temcad
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
Drug: 18F-FMISO
18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
Other Names:
  • Fluoromisonidazole
  • FMISO
Procedure: PET without SCS
PET-scanning using 18F-fluoromisonidazole without SCS
Other Names:
  • Positron emission tomography scanning
Radiation: Radiotherapy
Standard radiation therapy
Other Names:
  • Radiation therapy
Drug: Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Other Names:
  • Temodar
  • Temodal
  • Temcad
Device: SCS
Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.
Other Names:
  • Electrical Neurostimulation
  • Spinal Cord Stimulation
Procedure: PET without/with SCS
Second PET-scanning using 18F-fluoromisonidazole: without/with SCS
Other Names:
  • Positron emission tomography scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor hypoxia measurement using 18F-FMISO-PET (hypoxic volume and tumor/muscle ratio). Baseline measurement.
Time Frame: 18F-FMISO-PET between 1 and 3 weeks before the commencement of radio-chemotherapy
Tumor hypoxia will be measured in 20 patients with HGG using 18F-FMISO-PET: after biopsy or surgery and before the commencement of radio-chemotherapy. It will be assessed the prevalence and extent of significant hypoxia in HGG.
18F-FMISO-PET between 1 and 3 weeks before the commencement of radio-chemotherapy
Change from baseline tumor hypoxia using 18F-FMISO-PET (hypoxic volume and tumor/muscle ratio) during SCS.
Time Frame: 2nd 18F-FMISO-PET between 1 and 7 days after the 1st 18F-FMISO-PET
A subset of 10 patients will undergo a second 18F-FMISO-PET study during spinal cord stimulation to evaluate changes by SCS between 1 and 7 days after the first 18F-FMISO-PET study (and before the commencement of radio-chemotherapy).
2nd 18F-FMISO-PET between 1 and 7 days after the 1st 18F-FMISO-PET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between 18F-FMISO-PET values and pathological tumor parameters
Time Frame: Week 0 (at the commencement of radio-chemotherapy).
To analyze the correlation of 18F-FMISO-PET with histological parameters and tumor expression of: CD31 (vascular density), VEGF (vascular endothelial growth factor) and VEGFR (angiogenesis), EGFR (epidermal growth factor receptor), Ki-67 (proliferation index) and hypoxic markers
Week 0 (at the commencement of radio-chemotherapy).
Correlation with Karnofsky scale.
Time Frame: At 0, 2 and 9 months after the commencement of the radio-chemotherapy.
To analyze the correlation with performance status using the Karnofsky scale.
At 0, 2 and 9 months after the commencement of the radio-chemotherapy.
Correlation with the ECOG (Eastern Cooperative Oncology Group) performance status scale
Time Frame: At 0, 2 and 9 months after the commencement of the radio-chemotherapy
To analyze the correlation with performance status using the ECOG (WHO) scale.
At 0, 2 and 9 months after the commencement of the radio-chemotherapy
Correlation with the Quality of Life Questionnaire QLQ-C30 (EORTC)
Time Frame: At 0, 2 and 9 months after the commencement of the radio-chemotherapy.
To analyze the correlation with quality of life using the QLQ-C30 (EORTC) questionnaire.
At 0, 2 and 9 months after the commencement of the radio-chemotherapy.
Overall survival.
Time Frame: At 9 months after the commencement of the radio-chemotherapy.
To analyze the correlation with overall survival.
At 9 months after the commencement of the radio-chemotherapy.
Radiological response to treatment
Time Frame: 9 months after the commencement of radio-chemotherapy
To analyze the correlation between 18F-FMISO-PET values and radiological response to treatment
9 months after the commencement of radio-chemotherapy
Radiological location of tumor relapse or progression
Time Frame: 9 months after the commencement of radio-chemotherapy
To analyze the correlation between 18F-FMISO-PET values and the radiological location of tumor relapse or progression
9 months after the commencement of radio-chemotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow in carotid and middle cerebral arteries
Time Frame: Between 1 and 3 weeks before the commencement of radio-chemotherapy
To analyze the correlation between 18F-FMISO-PET values and blood flow in carotid and middle cerebral arteries (assessed before the commencement of radio-chemotherapy) using Doppler measurements.
Between 1 and 3 weeks before the commencement of radio-chemotherapy
Facial and supraciliar infrared emission
Time Frame: Between 1 and 3 weeks before the commencement of radio-chemotherapy
To analyze the correlation between 18F-FMISO-PET values and facial and supraciliar infrared emission (assessed by digital thermography)
Between 1 and 3 weeks before the commencement of radio-chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bernardino Clavo, MD, PhD

Collaborators

Instituto de Salud Carlos III
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Grupo de Investigación Clínica en Oncología Radioterapia
Instituto Canario de Investigación del Cáncer
RSbiomed
Fundación DISA, Canary Islands, Spain

Investigators

  • Study Chair: Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital, Las Palmas
  • Principal Investigator: Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital, Las Palmas
  • Principal Investigator: Francisco Robaina, MD, PhD, Dr. Negrin University Hospital, Las Palmas
  • Principal Investigator: Juan C Alonso, MD, PhD, Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 17, 2017

Study Completion (Actual)

September 17, 2017

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-FMISO-PET-06-1413 (Other Identifier: Dr. Negrin University Hospital)
  • 2009-015852-11 (EudraCT Number)
  • PI 06/1413, PI 12/02940 (Other Grant/Funding Number: Instituto de Salud Carlos III)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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