The Application of Glucose CEST MR Imaging in Brain Tumor

Sponsor

Zhujiang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04945499

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Magnetic Resonance Imaging	Drug: d-glucose	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 250 seconds.	Drug: d-glucose using d-glucose as an contrast agent on CEST MR Imaging Other Names: 50% dextrose injection

Arm

Intervention/Treatment

Other: 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 250 seconds.

Drug: d-glucose

using d-glucose as an contrast agent on CEST MR Imaging

Other Names:

50% dextrose injection

Outcome Measures

Primary Outcome Measures

CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema [1 week]
the CEST value of tumor core and necrosis might higher than white matter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510282

Sponsors and Collaborators

Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Dec 27, 2019

More Information

Publications

None provided.

Responsible Party:

Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT04945499

Other Study ID Numbers:

DGE CEST MR and brain tumor

First Posted:

Jun 30, 2021

Last Update Posted:

Jul 28, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Zhujiang Hospital

dynamic glucose enhanced

human brain tumor

chemical exchange saturation transfer

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Jul 28, 2021