Back to resultsThe 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
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
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
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
Learn more about this trial
The Application of Glucose CEST MR Imaging in Brain Tumor
We'll reach out to this number within 24 hrs