4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

Lung Cancer Clinical Trial

— GLN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568799
• Other study ID #: XH-17-012
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Hui Wang, MD
• Phone: 86-02125078590
• Email: wanghauishanghai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking Behavior
• Lung Cancer
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Intervention

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

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in lung cancer	Sensitivity, specificity, diagnostic accuracy of 4-[18F]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.	up to three years
Secondary	Incidence of Treatment-Emergent Adverse Events	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.	up to 30 days after the F-Gln imaging
Secondary	ASCT2 expression levels in tissue samples	Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)	up to three years