search
Back to results

Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

Primary Purpose

Cancer, Metastatic Cancer, Metastatic Brain Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-(2S,4R)4-fluoroglutamine
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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.

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)
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

Full Information

First Posted
October 24, 2018
Last Updated
September 5, 2019
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03721055
Brief Title
Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor
Official Title
18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 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

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 malignant tumor. [18F]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Metastatic Cancer, Metastatic Brain Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (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 malignant 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
Title
The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors
Description
Evaluating the prognostic value of metabolic parameters and clinical indexes by using log-rank tests on univariate analysis and COX proportional hazards regression tests
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wang, MD
Phone
86-02125078590
Email
wanghauishanghai@hotmail.com
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

Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

We'll reach out to this number within 24 hrs