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

Not Applicable

• Conditions: Solitary Pulmonary Nodule; Cigarette Smoking Behavior; Lung Cancer
• Interventions: Radiation: 18F-(2S,4R)4-fluoroglutamine

• Registration Number: NCT03568799
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-23
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-[18F]Fluoroglutamine	18F-(2S,4R)4-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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China