Cigarette Smoking Behavior, Lung Cancer, Solitary Pulmonary Nodule
Conditions
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.
Interventions
RADIATION18F-(2S,4R)4-fluoroglutamine
Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
Sponsors
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients are given the opportunity to participate in the study if 1. Age between 18-79; 2. The patient must be able to give informed consent; 3. 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; 4. Patients can finish PET/CT scan without tranquilizers; 5. 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. 6. 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 1. Pregnant or lactating patients; 2. Patients with active lung infection; 3. Inability or refusal to have at least one peripheral intravenous line for intravenous access; 4. 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； 5. Patients with a history of allergic reaction to this drugs or its analogues； 6. patients with poor compliance; 7. Acute major illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in lung 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactHui Wang, MD
Outcome results
None listed