Back to results4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules (GLN)
Primary Purpose
Lung Cancer, Solitary Pulmonary Nodule, Cigarette Smoking Behavior
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-(2S,4R)4-fluoroglutamine
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Sites / Locations
- Xinhua HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
4-[18F]Fluoroglutamine
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
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.
ASCT2 expression levels in tissue samples
Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)
Full Information
NCT ID
NCT03568799
First Posted
December 13, 2017
Last Updated
October 17, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03568799
Brief Title
4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Acronym
GLN
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Solitary Pulmonary Nodule, Cigarette Smoking Behavior
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
4-[18F]Fluoroglutamine
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
18F-(2S,4R)4-fluoroglutamine
Intervention Description
Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
Primary Outcome Measure Information:
Title
Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in lung cancer
Description
Sensitivity, specificity, diagnostic accuracy of 4-[18F]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.
Time Frame
up to three years
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
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.
Time Frame
up to 30 days after the F-Gln imaging
Title
ASCT2 expression levels in tissue samples
Description
Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)
Time Frame
up to three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wang, MD
Phone
86-02125078590
Email
wanghauishanghai@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Wang, MD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wang, MD
Phone
86-02125078590
Email
wanghauishanghai@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
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