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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Solitary Pulmonary Nodule; Cigarette Smoking Behavior; Lung Cancer

Treatments: Radiation: 18F-(2S,4R)4-fluoroglutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03568799

XH-17-012

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

4-[18F]Fluoroglutamine

Experimental group

Description:

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.

Treatment:

Radiation: 18F-(2S,4R)4-fluoroglutamine