Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

September 5, 2019 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-[18F]Fluoroglutamine
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
Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
Time Frame: up to three years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: up to 30 days after the F-Gln imaging
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
ASCT2 expression levels in tissue samples
Time Frame: up to three years
Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)
up to three years
The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors
Time Frame: up to three years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHEC-C-2017-029-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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