Clinical trial · Interventional
Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor
18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
NCT03721055CI-TRIAL-00040446unknownN/AClinicalTrials.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 studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. \[18F\]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Brain Cancer | Malignant Brain Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-(2S,4R)4-fluoroglutamine | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4-[18F]Fluoroglutamine
- description
- Patients undergo 18F-FDG PET/CT scan first. Within 7 working days, patients receive 4-\[18F\]Fluoroglutamine IV and 60 minutes after injection, undergo 4-\[18F\]Fluoroglutamine PET/CT before the start of therapy.
- interventionNames
- Radiation: 18F-(2S,4R)4-fluoroglutamine
Primary outcomes (1)
- measure
- Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
- timeFrame
- up to three years
- description
- Sensitivity, specificity, diagnostic accuracy of 4-\[18F\]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.
Secondary outcomes (3)
- measure
- Incidence of Treatment-Emergent Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18-79; * The patient must be able to give informed consent; * Patients can finish PET/CT scan without tranquilizers; * Patients with pathology-proven cancer or a tumor highly suspected to be malignant ; * Lesions can be measured and assessed at the RECIST 1.1 standard; * No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-\[18F\]Fluoroglutamine PET/CT. Exclusion Criteria: * Pregnant or lactating patients; * Inability or refusal to have at least one peripheral intravenous line for intravenous access; * From assays obtained \<2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin\>1.5\*ULN,AST/ALT \>2.5 \* ULN, Albumin\< 3 g/dl, GGT \> 2.5 x ULN if ALP\> 2.5 x ULN, Creatinine\>1.5\*ULN or creatinine clearance \<60ml/min； * Patients with a history of allergic reaction to this drugs or its analogues； * patients with poor compliance; * Acute major illness
References
Publications (0)
Data not yet available
No reference posted for this study.