Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

Not Applicable

• Conditions: Metastatic Brain Cancer; Metastatic Cancer; Cancer
• Interventions: Radiation: 18F-(2S,4R)4-fluoroglutamine

• Registration Number: NCT03721055
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-21
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-[18F]Fluoroglutamine	18F-(2S,4R)4-fluoroglutamine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China