[18F] 4-L-Fluoroglutamine (2S,4R) PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country30 target enrollmentJune 23, 2017

ConditionsLung Cancer Solitary Pulmonary Nodule Cigarette Smoking Behavior

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment: 30
Locations: 1
Primary Endpoint: Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in lung cancer
Last Updated: 7 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 Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules. [18F]Fluoroglutamine PET may provide additional information that help diagnose lung cancer.

Registry

clinicaltrials.gov

Start Date

June 23, 2017

End Date

December 31, 2019

Last Updated

7 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

•Patients are given the opportunity to participate in the study if
•Age between 18-79;
•The patient must be able to give informed consent;
•Sexually active subjects agree to use condoms and/or their partners of reproductive potential to use a method of effective birth control during imaging period of 2 weeks;
•Patients can finish PET/CT scan without tranquilizers;
•Patients with a newly diagnosed, untreated primary lung cancer; Or patients older than 55, current or former smoking with ≥ 30 pack years, and newly discovered indeterminate pulmonary nodules (7-30 mm diameter) on CT.
•No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-\[18F\]Fluoroglutamine PET/CT.

Exclusion Criteria

•Patients with any of the following conditions will be excluded
•Pregnant or lactating patients;
•Patients with active lung infection;
•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 lung 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.