Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Metastatic Cancer Metastatic Brain Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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4-[18F]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.

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT

Interventions

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

Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No