18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country60 target enrollmentAugust 21, 2017

ConditionsCancer Metastatic Cancer Metastatic Brain Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment: 60
Locations: 1
Primary Endpoint: Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 21, 2017

End Date

December 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer

Time Frame: 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 Outcomes

The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors(up to three years)
Incidence of Treatment-Emergent Adverse Events(up to 30 days after the F-Gln imaging)
ASCT2 expression levels in tissue samples(up to three years)