Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

Cancer Clinical Trial

Official title:

18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03721055
• Other study ID #: XHEC-C-2017-029-2
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Hui Wang, MD
• Phone: 86-02125078590
• Email: wanghauishanghai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. [18F]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Age between 18-79;

• The patient must be able to give informed consent;

• Patients can finish PET/CT scan without tranquilizers;

• Patients with pathology-proven cancer or a tumor highly suspected to be malignant ;

• Lesions can be measured and assessed at the RECIST 1.1 standard;

• No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-[18F]Fluoroglutamine PET/CT.

Exclusion Criteria:

• Pregnant or lactating patients;

• 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

Related Conditions & MeSH terms

• Brain Neoplasms
• Cancer
• Metastatic Brain Cancer
• Metastatic Cancer
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant 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	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.	up to 30 days after the F-Gln imaging
Secondary	ASCT2 expression levels in tissue samples	Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)	up to three years
Secondary	The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors	Evaluating the prognostic value of metabolic parameters and clinical indexes by using log-rank tests on univariate analysis and COX proportional hazards regression tests	up to three years