Clinical trial NCT04945499: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Magnetic Resonance Imaging
Keywords: dynamic glucose enhanced
human brain tumor
chemical exchange saturation transfer
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: