Clinical trial NCT03568799: 4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Official title: [18F] 4-L-Fluoroglutamine (2S,4R) PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Solitary Pulmonary Nodule
Cigarette Smoking Behavior
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Institute of Materia Medica, Chinese Academy of Sciences
First posted: 2018-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in lung cancer
timeFrame: up to three years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 30 days after the F-Gln imaging
measure: ASCT2 expression levels in tissue samples
timeFrame: up to three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Hui Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: