Clinical trial · Interventional
FMISO-PET in Brain Tumors and SCS Effect
Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Isotope (FMISO) production is no longer available in our country.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FMISO | Drug | — | UNRESOLVED |
| PET without SCS | Procedure | — | UNRESOLVED |
| PET without/with SCS | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| SCS | Device | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm-A: 18F-FMISO-PET without SCS
- description
- One 18F-FMISO-PET study for assessment of tumor hypoxia before radiotherapy and Temozolomide, without spinal cord stimulation.
- interventionNames
- Drug: 18F-FMISO
- Procedure: PET without SCS
- Radiation: Radiotherapy
- Drug: Temozolomide
- type
- OTHER
- label
- Arm-B: 18F-FMISO-PET without/with SCS
- description
- Two 18F-FMISO-PET studies for assessment of tumor hypoxia before radiotherapy and Temozolomide: one "without" and one "with" spinal cord stimulation
- interventionNames
- Drug: 18F-FMISO
- Procedure: PET without SCS
- Device: SCS
- Procedure: PET without/with SCS
- Radiation: Radiotherapy
- Drug: Temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDClavo 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. PMID 11795721
- BACKGROUNDClavo 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. PMID 12816274
- BACKGROUNDClavo 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. PMID 15111351
- BACKGROUNDClavo 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. PMID 16619657
- BACKGROUNDRobaina 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. PMID 22151123
- BACKGROUNDClavo 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. PMID 18513465
- BACKGROUNDClavo 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.