The Application of Glucose CEST MR Imaging in Brain Tumor

The Evaluation of D-glucose Weighted Chemical Exchange Saturation Transfer (gluceoCEST)-Based Dynamic Glucose Enhanced(DGE) Magnetic Resonance Imaging（MRI） in Brain Tumor

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).

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Drug: d-glucose

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zhibo Wen, PhD; Phone Number: 020-643461; Email: zhibowen@163.com
• Study Contact Backup: Name: Jianhua Mo, MD; Phone Number: 15627283832; Email: 154036203@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: zhibo wen, PhD; Phone Number: 020-61643461; Email: zhibowen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (ACTUAL): June 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: dynamic glucose enhanced; human brain tumor; chemical exchange saturation transfer
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: DGE CEST MR and brain tumor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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