Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

Shanghai Jiao Tong University

Status: Unknown

Conditions: Metastatic Cancer; Cancer; Metastatic Brain Cancer

Treatments: Radiation: 18F-(2S,4R)4-fluoroglutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03721055

XHEC-C-2017-029-2

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

4-[18F]Fluoroglutamine

Experimental group

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.

Treatment:

Radiation: 18F-(2S,4R)4-fluoroglutamine