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

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03568799
• Collaborator: Shanghai Institute of Materia Medica, Chinese Academy of Sciences (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Solitary Pulmonary Nodule; Cigarette Smoking Behavior	Radiation: 18F-(2S,4R)4-fluoroglutamine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: [18F] 4-L-Fluoroglutamine (2S,4R) PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
• Actual Study Start Date: Jun 23, 2017
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Radiation: 18F-(2S,4R)4-fluoroglutamine; Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts 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>1.5ULN,AST/ALT >2.5 * ULN, Albumin< 3 g/dl, GGT > 2.5 x ULN if ALP> 2.5 x ULN, Creatinine>1.5ULN 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital	Shanghai	Shanghai	China	200092

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Hui Wang, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT03568799
• Other Study ID Numbers: XH-17-012
• First Posted: Jun 26, 2018
• Last Update Posted: Oct 19, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

No Results Posted as of Oct 19, 2018