Clinical trial · Interventional
Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma
Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors
NCT05045027CI-TRIAL-00097199active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.
Conditions
Conditions (4)
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 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Glioma | Glioma | CURATED_BROADER | 0.78 |
| Recurrent Malignant Glioma | Malignant Glioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Diagnostic Imaging | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Basic science (MRI, metabolic imaging, tissue collection)
- description
- AIM 1: Previous scan data from healthy subjects is collected and analyzed. AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis. AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Diagnostic Imaging
- Procedure: Magnetic Resonance Imaging
Primary outcomes (3)
- measure
- Total sodium concentration
- timeFrame
- Up to 5 years
- description
- Will calculate NaT using standard methodology and normalize it to ocular Na+ concentration, a constant 135 mmol/l. Will then test whether healthy tissue has a coefficient of variance (COV) of \< 10% across all 20 subjects.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease * AIM 1: Age 18+ * AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade) * AIM 2: 10 IDH mutant and 10 IDH wild type gliomas * AIM 2: Clinically indicated for resective surgery or biopsy * AIM 2: Age 18+ * AIM 2: Tumor size \> 1x1x1 cm (measurable) * AIM 3: Recurrent glioma enrolled in an immunotherapy trial or clinically indicated to receive immunotherapy including anti-PD1 * AIM 3: Age 18+ Exclusion Criteria: * AIM 1: Cannot safely perform an MRI * AIM 1: Age \< 18 * AIM 2: Cannot safely perform an MRI or use of MRI contrast agents * AIM 2: Age \< 18 * AIM 3: Cannot safely perform an MRI or use of MRI contrast agents * AIM 3: Age \< 18
References
Publications (0)
Data not yet available
No reference posted for this study.