Clinical trial · Interventional
BBPA PET/CT in Patients With Malignant Tumors
Safety and Clinical Value of 18Fluorine-labeled BBPA PET/CT in Patients With Malignant Tumors
- 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 study is an open-labeled phase II diagnostic clinical trial to explore the safety and clinical value of BBPA-PET/CT in suspected malignant tumor patients. The investigation regarding the clinical value of BBPA concerning the metabolic characteristics of BBPA in suspected malignant tumors. Quantitative features will be extracted to analysis the PET images. For patient who took surgery after multiple examination, histopathology, molecular pathology and LAT-1 immunohistochemistry will also be obtained.
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 Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BBPA PET examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Malignant Tumors
- description
- BBPA in suspected malignant tumors. This arm investigates the metabolic characteristics of BBPA in suspected malignant tumor patients who consider for surgical operations. A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later. Surgical operations, if recommended after multiple examination, will be carried out within 1 week after BBPA PET scan.
- interventionNames
- Diagnostic Test: BBPA PET examination
Primary outcomes (1)
- measure
- standardized uptake value (SUV) for BBPA
- timeFrame
- 1 week
- description
- SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually assessed features will be measured in the evaluation of tumors.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have suspected diagnosis of brain tumors, based on clinical performance and imaging results. * Meet the indications for PET examination, show a clear indication and no contraindications; * Have a performance status of score ≥80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation; * Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * Be ≥ 18 years of age on day of signing informed consent. * Be willing and able to understand the research content and provide written informed consent/assent for the trial. Exclusion Criteria: * Have a history of imaging agent allergies; * Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination; * Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; * Unable to adhere strictly to protocol requirements.
References
Publications (0)
Data not yet available