Clinical trial · Interventional
Image Guided Therapy in the Treatment of Gliomas
Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
NCT01263821CI-TRIAL-00028945terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain. PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.
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 |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| Functional magnetic resonance imaging | Procedure | — | UNRESOLVED |
| Intensity-modulated radiation therapy | Procedure | — | UNRESOLVED |
| Magnetic resonance spectroscopic imaging | Procedure | — | UNRESOLVED |
| Perfusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| Quality-of-life assessment | Procedure | — | UNRESOLVED |
| Questionnaire administration | Other | — | UNRESOLVED |
| Radiation therapy treatment planning/simulation | Procedure |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
- interventionNames
- Procedure: Diffusion-weighted magnetic resonance imaging
- Procedure: Perfusion-weighted magnetic resonance imaging
- Procedure: Functional magnetic resonance imaging
- Procedure: Magnetic resonance spectroscopic imaging
- Procedure: Therapeutic conventional surgery
- Procedure: Quality-of-life assessment
- Procedure: Radiation therapy treatment planning/simulation
- Procedure: Intensity-modulated radiation therapy
- Other: Questionnaire administration
Primary outcomes (1)
- measure
- Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, newly diagnosed intracranial glioma * A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration * Karnofsky performance status \>= 60 * Ability to undergo MR imaging with the use of Gadolinium dye * Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative Exclusion Criteria: * Inability to obtain histological proof of glioma * Allergy to Gadolinium contrast * Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging * Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration * Karnofsky performance status of =\< 50 * Prior history of radiation therapy to the brain * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.