Clinical trial · Observational
68Ga-citrate PET/MR Imaging for Glioma
68Ga-citrate PET/MR Imaging for the Evaluation of Glioma in Adults
NCT03335280CI-TRIAL-00044927terminatedClinicalTrials.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): Low Accrual
Summary
Brief summary (as posted)
This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-citrate PET/MR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Positive for PTEN deletion
- description
- Confirmed by immunohistochemistry of tissue biopsy
- interventionNames
- Drug: 68Ga-citrate PET/MR
- label
- Negative for PTEN deletion
- description
- Confirmed by immunohistochemistry of tissue biopsy
- interventionNames
- Drug: 68Ga-citrate PET/MR
Primary outcomes (1)
- measure
- Maximum standardized uptake value (SUVmax)
- timeFrame
- 1 day
- description
- The location and extent of 68Ga-citrate uptake will be compared to both same day magnetic resonance imaging (MRI) and subsequent pathology. SUVmax will be the outcome of interest and summarized with descriptive measures. SUVmax will be compared via a two-sided two-sample equal-variance t-test between those patients positive for PTEN deletion and those negative for PTEN deletion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * World Health Organization (WHO) grade 3 or 4 glioma planning to undergo surgery * Age \>= 18 yrs. * Karnofsky performance status of \>= 60 * Ability to understand a written informed consent document, and the willingness to sign it. Cohort A: \- Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy Cohort B: \- Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy Exclusion Criteria: * Contraindications to Positron Emission Tomography (PET) imaging (e.g. pregnant or breast-feeding woman) * Contraindications to magnetic resonance (MR) imaging (e.g. pacemakers, metallic implants, etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.