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Malignant GliomaPhase 2FMISOPETSCSNCT01868906

FMISO-PET in Brain Tumors and SCS Effect

A Phase 2 study testing 18F-FMISO, PET without SCS and SCS in people with Malignant Glioma, run by Bernardino Clavo, MD, PhD at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Glioma
What is being tested?
18F-FMISO, PET without SCS and SCS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesSpain
Study dates
Jun 2013to 17 Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Spain2 sites

  • Dr. Negrin University Hospital

    Las Palmas, 35010

  • Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid

    Madrid, 28.033

Other trials in Spain

About this study

Official title: 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.

Read the 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).

Being tested
18F-FMISO, PET without SCS, SCS, PET without/with SCS, Radiotherapy
Keywords
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
Medical subject headings
Glioma, Astrocytoma, Brain Neoplasms, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FMISODrug

    Also called Fluoromisonidazole, FMISO

    18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.

  • PET without SCSProcedure or surgery

    Also called Positron emission tomography scanning

    PET-scanning using 18F-fluoromisonidazole without SCS

  • SCSDevice

    Also called Electrical Neurostimulation, Spinal Cord Stimulation

    Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.

  • PET without/with SCSProcedure or surgery

    Also called Positron emission tomography scanning

    Second PET-scanning using 18F-fluoromisonidazole: without/with SCS

  • RadiotherapyRadiation

    Also called Radiation therapy

    Standard radiation therapy

  • TemozolomideDrug

    Also called Temodar, Temodal, Temcad

    Standard treatment with concurrent and adjuvant Temozolomide.

Study groups in NCT01868906
Study groupRoleWhat they receive
Arm-A: 18F-FMISO-PET without SCSOtherOne 18F-FMISO-PET study for assessment of tumor hypoxia before radiotherapy and Temozolomide, without spinal cord stimulation.
Receives: Drug: 18F-FMISO; Procedure: PET without SCS; Radiation: Radiotherapy; Drug: Temozolomide
Arm-B: 18F-FMISO-PET without/with SCSOtherTwo 18F-FMISO-PET studies for assessment of tumor hypoxia before radiotherapy and Temozolomide: one "without" and one "with" spinal cord stimulation
Receives: Drug: 18F-FMISO; Procedure: PET without SCS; Device: SCS; Procedure: PET without/with SCS; Radiation: Radiotherapy; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor hypoxia measurement using 18F-FMISO-PET (hypoxic volume and tumor/muscle ratio). Baseline measurement.

    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.

    Measured: 18F-FMISO-PET between 1 and 3 weeks before the commencement of radio-chemotherapy

  2. Change from baseline tumor hypoxia using 18F-FMISO-PET (hypoxic volume and tumor/muscle ratio) during SCS.

    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).

    Measured: 2nd 18F-FMISO-PET between 1 and 7 days after the 1st 18F-FMISO-PET

Secondary outcomes (7)

  1. Correlation between 18F-FMISO-PET values and pathological tumor parameters

    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

    Measured: Week 0 (at the commencement of radio-chemotherapy).

  2. Correlation with Karnofsky scale.

    To analyze the correlation with performance status using the Karnofsky scale.

    Measured: At 0, 2 and 9 months after the commencement of the radio-chemotherapy.

  3. Correlation with the ECOG (Eastern Cooperative Oncology Group) performance status scale

    To analyze the correlation with performance status using the ECOG (WHO) scale.

    Measured: At 0, 2 and 9 months after the commencement of the radio-chemotherapy

  4. Correlation with the Quality of Life Questionnaire QLQ-C30 (EORTC)

    To analyze the correlation with quality of life using the QLQ-C30 (EORTC) questionnaire.

    Measured: At 0, 2 and 9 months after the commencement of the radio-chemotherapy.

  5. Overall survival.

    To analyze the correlation with overall survival.

    Measured: At 9 months after the commencement of the radio-chemotherapy.

  6. Radiological response to treatment

    To analyze the correlation between 18F-FMISO-PET values and radiological response to treatment

    Measured: 9 months after the commencement of radio-chemotherapy

  7. Radiological location of tumor relapse or progression

    To analyze the correlation between 18F-FMISO-PET values and the radiological location of tumor relapse or progression

    Measured: 9 months after the commencement of radio-chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion17 Sep 2017
  4. Study completion17 Sep 2017

Why it stopped: Isotope (FMISO) production is no longer available in our country.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01868906
Sponsor's protocol ID
TC-FMISO-PET-06-1413
Other IDs
2009-015852-11, PI 06/1413, PI 12/02940, TC-FMISO-PET-06-1413, 2009
Acronym
FMISOPETSCS
Status last verified
Aug 2018
First submitted
24 May 2010
Last updated
24 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Clavo B, Robaina F, Morera J, Ruiz-Egea E, Perez JL, Macias D, Carames MA, Catala L, Hernandez MA, Gunderoth M. Increase of brain tumor oxygenation during cervical spinal cord stimulation. Report of three cases. J Neurosurg. 2002 Jan;96(1 Suppl):94-100. doi: 10.3171/spi.2002.96.1.0094.

    PubMed 11795721

  • Clavo B, Robaina F, Catala L, Valcarcel B, Morera J, Carames MA, Ruiz-Egea E, Panero F, Lloret M, Hernandez MA. Increased locoregional blood flow in brain tumors after cervical spinal cord stimulation. J Neurosurg. 2003 Jun;98(6):1263-70. doi: 10.3171/jns.2003.98.6.1263.

    PubMed 12816274

  • Clavo B, Robaina F, Catala L, Perez JL, Lloret M, Carames MA, Morera J, Lopez L, Suarez G, Macias D, Rivero J, Hernandez MA. Effect of cervical spinal cord stimulation on regional blood flow and oxygenation in advanced head and neck tumours. Ann Oncol. 2004 May;15(5):802-7. doi: 10.1093/annonc/mdh189.

    PubMed 15111351

  • Clavo B, Robaina F, Montz R, Domper M, Carames MA, Morera J, Pinar B, Hernandez MA, Santullano V, Carreras JL. Modification of glucose metabolism in brain tumors by using cervical spinal cord stimulation. J Neurosurg. 2006 Apr;104(4):537-41. doi: 10.3171/jns.2006.104.4.537.

    PubMed 16619657

  • Robaina F, Clavo B, Catala L, Carames MA, Morera J. Blood flow increase by cervical spinal cord stimulation in middle cerebral and common carotid arteries. Neuromodulation. 2004 Jan;7(1):26-31. doi: 10.1111/j.1525-1403.2004.04003.x.

    PubMed 22151123

  • Clavo B, Robaina F, Montz R, Carames MA, Otermin E, Carreras JL. Effect of cervical spinal cord stimulation on cerebral glucose metabolism. Neurol Res. 2008 Jul;30(6):652-4. doi: 10.1179/174313208X305373. Epub 2008 May 29.

    PubMed 18513465

  • Clavo B, Robaina F, Montz R, Carames MA, Lloret M, Ponce P, Hernandez MA, Carreras JL. Modification of glucose metabolism in radiation-induced brain injury areas using cervical spinal cord stimulation. Acta Neurochir (Wien). 2009 Nov;151(11):1419-25. doi: 10.1007/s00701-009-0400-8. Epub 2009 Jun 5.

    PubMed 19499176

  • Clavo B, Robaina F, Valcarcel B, Catala L, Perez JL, Cabezon A, Jorge IJ, Fiuza D, Hernandez MA, Jover R, Carreras JL. Modification of loco-regional microenvironment in brain tumors by spinal cord stimulation. Implications for radio-chemotherapy. J Neurooncol. 2012 Jan;106(1):177-84. doi: 10.1007/s11060-011-0660-z. Epub 2011 Jul 12.

    PubMed 21748490

  • Overgaard J. Hypoxic radiosensitization: adored and ignored. J Clin Oncol. 2007 Sep 10;25(26):4066-74. doi: 10.1200/JCO.2007.12.7878.

    PubMed 17827455

  • Spence AM, Muzi M, Swanson KR, O'Sullivan F, Rockhill JK, Rajendran JG, Adamsen TC, Link JM, Swanson PE, Yagle KJ, Rostomily RC, Silbergeld DL, Krohn KA. Regional hypoxia in glioblastoma multiforme quantified with [18F]fluoromisonidazole positron emission tomography before radiotherapy: correlation with time to progression and survival. Clin Cancer Res. 2008 May 1;14(9):2623-30. doi: 10.1158/1078-0432.CCR-07-4995.

    PubMed 18451225

  • Clavo B, Robaina F, Jorge IJ, Cabrera R, Ruiz-Egea E, Szolna A, Otermin E, Llontop P, Carames MA, Santana-Rodriguez N, Sminia P. Spinal cord stimulation as adjuvant during chemotherapy and reirradiation treatment of recurrent high-grade gliomas. Integr Cancer Ther. 2014 Nov;13(6):513-9. doi: 10.1177/1534735414550037. Epub 2014 Sep 15.

    PubMed 25228535

  • Clavo B, Robaina F, Fiuza D, Ruiz A, Lloret M, Rey-Baltar D, Llontop P, Riveros A, Rivero J, Castaneda F, Quintero S, Santana-Rodriguez N. Predictive value of hypoxia in advanced head and neck cancer after treatment with hyperfractionated radio-chemotherapy and hypoxia modification. Clin Transl Oncol. 2017 Apr;19(4):419-424. doi: 10.1007/s12094-016-1541-x. Epub 2016 Aug 15.

    PubMed 27527617

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-FMISO, PET without SCS and SCS in people with Malignant Glioma, run by Bernardino Clavo, MD, PhD at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Isotope (FMISO) production is no longer available in our country.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01868906, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.

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