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

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ClinicalTrials.gov Identifier: NCT01868906
Recruitment Status : Terminated (Isotope (FMISO) production is no longer available in our country.)
First Posted : June 5, 2013
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Instituto de Salud Carlos III
Grupo de Investigación Clínica en Oncología Radioterapia
Instituto Canario de Investigación del Cáncer
RSbiomed
Fundación DISA, Canary Islands, Spain
Information provided by (Responsible Party):
Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital

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 pathological, imaging and clinical parameters will be analyzed.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: 18F-FMISO Procedure: PET without SCS Device: SCS Procedure: PET without/with SCS Radiation: Radiotherapy Drug: Temozolomide Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation
Study Start Date : June 2013
Actual Primary Completion Date : September 17, 2017
Actual Study Completion Date : September 17, 2017


Arm Intervention/treatment
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 Name: Positron emission tomography scanning

Radiation: Radiotherapy
Standard radiation therapy
Other Name: Radiation therapy

Drug: Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Other Names:
  • Temodar
  • Temodal
  • Temcad

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 Name: Positron emission tomography scanning

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 Name: Positron emission tomography scanning

Radiation: Radiotherapy
Standard radiation therapy
Other Name: Radiation therapy

Drug: Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Other Names:
  • Temodar
  • Temodal
  • Temcad




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Overall survival. [ Time Frame: At 9 months after the commencement of the radio-chemotherapy. ]
    To analyze the correlation with overall survival.

  6. 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

  7. 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


Other Outcome Measures:
  1. 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.

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868906


Locations
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Spain
Dr. Negrin University Hospital
Las Palmas, Spain, 35010
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Madrid, Spain, 28.033
Sponsors and Collaborators
Bernardino Clavo, MD, PhD
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Instituto de Salud Carlos III
Grupo de Investigación Clínica en Oncología Radioterapia
Instituto Canario de Investigación del Cáncer
RSbiomed
Fundación DISA, Canary Islands, Spain
Investigators
Layout table for investigator information
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:

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Responsible Party: Bernardino Clavo, MD, PhD, Radiation Oncologist, MD, PhD, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT01868906     History of Changes
Other Study ID Numbers: TC-FMISO-PET-06-1413
2009-015852-11 ( EudraCT Number )
PI 06/1413, PI 12/02940 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
TC-FMISO-PET-06-1413 ( Other Identifier: Dr. Negrin University Hospital )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Keywords provided by Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital:
Anaplastic Astrocytoma
Brain Tumors
Cancer Imaging
Fluoromisonidazole
FMISO PET
Glioblastoma
High Grade Glioma
Hypoxia Modification
Positron Emission Tomography
Radiation-Sensitizing Agents
Spinal Cord Stimulation
Tumor Hypoxia Measurement
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Misonidazole
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents