The Application of Glucose CEST MR Imaging in Brain Tumor

Zhujiang Hospital

Status and phase: Unknown; Early Phase 1

Conditions: Magnetic Resonance Imaging

Treatments: Drug: d-glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT04945499

DGE CEST MR and brain tumor

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

D-glucose

Other group

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.

Treatment:

Drug: d-glucose