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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04945499
Other study ID # DGE CEST MR and brain tumor
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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