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

NCT03568799 | Unknown DMC

• 1 other identifier: XH-17-012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Solitary Pulmonary Nodule; Cigarette Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  up to 30 days after the F-Gln imaging

• ASCT2 expression levels in tissue samples

  up to three years

Study Arms (1)

4-[18F]Fluoroglutamine

EXPERIMENTAL

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

Interventions

18F-(2S,4R)4-fluoroglutamine RADIATION

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

4-[18F]Fluoroglutamine

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are given the opportunity to participate in the study if
• Age between 18-79;
• The patient must be able to give informed consent;
• 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;
• Patients can finish PET/CT scan without tranquilizers;
• 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.
• No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-\[18F\]Fluoroglutamine PET/CT.

You may not qualify if:

• Patients with any of the following conditions will be excluded
• Pregnant or lactating patients;
• Patients with active lung infection;
• Inability or refusal to have at least one peripheral intravenous line for intravenous access;
• 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；
• Patients with a history of allergic reaction to this drugs or its analogues；
• patients with poor compliance;
• Acute major illness

Sponsors & Collaborators

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

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Solitary Pulmonary Nodule; Cigarette Smoking

Interventions

4-fluoroglutamine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Hui Wang, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wang, MD

CONTACT

86-02125078590; wanghauishanghai@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: June 26, 2018
• Study Start: June 23, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

CN (1)