Cancer Clinical Trial
Official title:
18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Xinhua Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer | Sensitivity, specificity, diagnostic accuracy of 4-[18F]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test. | up to three years | |
Secondary | Incidence of Treatment-Emergent Adverse Events | 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. | up to 30 days after the F-Gln imaging | |
Secondary | ASCT2 expression levels in tissue samples | Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2) | up to three years | |
Secondary | The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors | Evaluating the prognostic value of metabolic parameters and clinical indexes by using log-rank tests on univariate analysis and COX proportional hazards regression tests | up to three years |
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