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The Application of Glucose CEST MR Imaging in Brain Tumor

Primary Purpose

Magnetic Resonance Imaging

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
d-glucose
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Magnetic Resonance Imaging focused on measuring dynamic glucose enhanced, human brain tumor, chemical exchange saturation transfer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must have a brain mass consistent with a primary brain tumor or metastatic brain tumor
  • able to give consent and willingness to participate in this study.

Exclusion Criteria:

  • presence of any ferromagnetic implant (cardiac pacemakers, aneurysm clip, etc.)
  • pregnancy
  • claustrophobia or anxiety disorder
  • history of vertigo
  • persons with diabetes mellitus (self-report or HbA1C >= 6.5%)
  • Sickle cell disease
  • persons taking prescription medicine for hypertension
  • blood iron deficiency (Hb concentration < 11 g/dL or Hct < 32%)
  • If volunteering for MRI: history of kidney disease and/or eGFR < 60.
  • Middle-ear disorder
  • double vision
  • Seizure disorder
  • Multiple myeloma
  • Solid organ transplant
  • History of severe hepatic disease/liver transplant/pending liver transplant

Sites / Locations

  • Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

D-glucose

Arm Description

During the dynamic glucose scan, a brief hyperglycemic state was established by intravenous infusion of hospital-grade D50 glucose (D50, 25 g of dextrose in 50 mL of water sterile solution), followed by 20 mL of saline solution in 1 arm. The glucose infusion was performed using a power injector at an infusion rate of 0.2 mL/s, corresponding to total infusion times 250 seconds.

Outcomes

Primary Outcome Measures

CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema
the CEST value of tumor core and necrosis might higher than white matter

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
July 26, 2021
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04945499
Brief Title
The Application of Glucose CEST MR Imaging in Brain Tumor
Official Title
The Evaluation of D-glucose Weighted Chemical Exchange Saturation Transfer (gluceoCEST)-Based Dynamic Glucose Enhanced(DGE) Magnetic Resonance Imaging(MRI) in Brain Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Recently, natural D-glucose was suggested as a potential biodegradable contrast agent. The feasibility of using D-glucose for dynamic perfusion imaging was explored to detect malignant brain tumors based on blood brain barrier breakdown. Our study try to evaluate the feasibility of dynamic glucose enhanced(DGE) magnetic resonance imaging(MRI)in brain tumor, which based on D-glucose weighted chemical exchange saturation transfer (gluceoCEST).
Detailed Description
methods: Brain tumor patients were recruited. Time-resolved glucose signal changes were detected using chemical exchange saturation transfer (glucoCEST) MRI. Dynamic glucose enhanced (DGE) MRI was used to measure tissue response to an intravenous bolus of D-glucose. During the dynamic glucose scan, a brief hyperglycemic state was established by intravenous infusion of hospital-grade D50 glucose (D50, 25 g of dextrose in 50 mL of water sterile solution), followed by 20 mL of saline solution in 1 arm. The glucose infusion was performed using a power injector at an infusion rate of 0.2 mL/s, corresponding to total infusion times of 250 seconds. Performing contrast enhancement based on Gd-DTPA in 30 minutes later, which was used for comparison as golden standard. The area of hyperintensity will be measured, which represents the area of brain tumor. Differential test and Consistency analysis were used for statistical analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Imaging
Keywords
dynamic glucose enhanced, human brain tumor, chemical exchange saturation transfer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D-glucose
Arm Type
Other
Arm Description
During the dynamic glucose scan, a brief hyperglycemic state was established by intravenous infusion of hospital-grade D50 glucose (D50, 25 g of dextrose in 50 mL of water sterile solution), followed by 20 mL of saline solution in 1 arm. The glucose infusion was performed using a power injector at an infusion rate of 0.2 mL/s, corresponding to total infusion times 250 seconds.
Intervention Type
Drug
Intervention Name(s)
d-glucose
Other Intervention Name(s)
50% dextrose injection
Intervention Description
using d-glucose as an contrast agent on CEST MR Imaging
Primary Outcome Measure Information:
Title
CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema
Description
the CEST value of tumor core and necrosis might higher than white matter
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must have a brain mass consistent with a primary brain tumor or metastatic brain tumor able to give consent and willingness to participate in this study. Exclusion Criteria: presence of any ferromagnetic implant (cardiac pacemakers, aneurysm clip, etc.) pregnancy claustrophobia or anxiety disorder history of vertigo persons with diabetes mellitus (self-report or HbA1C >= 6.5%) Sickle cell disease persons taking prescription medicine for hypertension blood iron deficiency (Hb concentration < 11 g/dL or Hct < 32%) If volunteering for MRI: history of kidney disease and/or eGFR < 60. Middle-ear disorder double vision Seizure disorder Multiple myeloma Solid organ transplant History of severe hepatic disease/liver transplant/pending liver transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhibo Wen, PhD
Phone
020-643461
Email
zhibowen@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Mo, MD
Phone
15627283832
Email
154036203@qq.com
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhibo wen, PhD
Phone
020-61643461
Email
zhibowen@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Application of Glucose CEST MR Imaging in Brain Tumor

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