Cancer, Metastatic Brain Cancer, Metastatic Cancer
Conditions
Brief summary
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.
Interventions
RADIATION18F-(2S,4R)4-fluoroglutamine
Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer | up to three years | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | up to 30 days after the F-Gln imaging | The evaluation of the Incidence of Treatment-Emergent Adverse Events starts from the day of F-Gln examination until 30 days later; Treatment-Emergent Adverse Events are evaluated according to version 4.03 CTC-AE criteria. |
| ASCT2 expression levels in tissue samples | up to three years | Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2) |
| The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors | up to three years | Evaluating the prognostic value of metabolic parameters and clinical indexes by using log-rank tests on univariate analysis and COX proportional hazards regression tests |
Countries
China
Contacts
Primary ContactHui Wang, MD
Outcome results
None listed