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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03721055
Other study ID # XHEC-C-2017-029-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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