The Application of Glucose CEST MR Imaging in Brain Tumor

Magnetic Resonance Imaging Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945499
• Other study ID #: DGE CEST MR and brain tumor
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2021
• Source: Zhujiang Hospital
• Contact: Zhibo Wen, PhD
• Phone: 020-643461
• Email: zhibowen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Magnetic Resonance Imaging

Intervention

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

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema	the CEST value of tumor core and necrosis might higher than white matter	1 week