Clinical trial · Interventional
68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
NCT02520882CI-TRIAL-00026872unknownEarly 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 is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-Aca-BBN | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-Aca-BBN(7-14) PET/CT
- description
- The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.
- interventionNames
- Drug: 68Ga-NOTA-Aca-BBN
- Device: PET/CT
Primary outcomes (1)
- measure
- Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma
- timeFrame
- 1 year
- description
- The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in primary glioma will be measured.
Secondary outcomes (1)
- measure
- Adverse events collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Must be able to provide a written informed consent * Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma. * The tumor will be surgically removed and histological diagnosis will be available. Exclusion Criteria: * Females planning to bear a child recently or with childbearing potential； * Known severe allergy or hypersensitivity to IV radiographic contrast； * Inability to lie still for the entire imaging time because of cough, pain, etc. * Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. * Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.