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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 24, 2010
First Posted Date  ICMJE June 5, 2013
Last Update Posted Date August 24, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
  • Tumor hypoxia measurement using 18F-FMISO-PET (hypoxic volume and maximum tissue/blood 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.
  • Change from baseline tumor hypoxia using 18F-FMISO-PET (hypoxic volume and maximum tissue/blood 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).
Change History Complete list of historical versions of study NCT01868906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
  • 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
  • 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.
  • 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.
  • 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.
  • Overall survival. [ Time Frame: At 9 months after the commencement of the radio-chemotherapy. ]
    To analyze the correlation with overall survival.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2013)
  • 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.
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE FMISO-PET in Brain Tumors and SCS Effect
Official Title  ICMJE Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Malignant Glioma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: 18F-FMISO
    • Procedure: PET without SCS
    • Radiation: Radiotherapy
    • Drug: Temozolomide
  • 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
    • Procedure: PET without SCS
    • Device: SCS
    • Procedure: PET without/with SCS
    • Radiation: Radiotherapy
    • Drug: Temozolomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 17, 2017)
6
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2013)
20
Actual Study Completion Date  ICMJE September 17, 2017
Actual Primary Completion Date September 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868906
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital
Study Sponsor  ICMJE Bernardino Clavo, MD, PhD
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Dr. Negrin University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP