Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Application of Glucose CEST MR Imaging in Brain Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04945499
Recruitment Status : Recruiting
First Posted : June 30, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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).

Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Drug: d-glucose Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
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 Name: 50% dextrose injection




Primary Outcome Measures :
  1. CEST value of tumor lesion including tumor core/ necrosis/ cysis/ edema [ Time Frame: 1 week ]
    the CEST value of tumor core and necrosis might higher than white matter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04945499


Contacts
Layout table for location contacts
Contact: Zhibo Wen, PhD 020-643461 zhibowen@163.com
Contact: Jianhua Mo, MD 15627283832 154036203@qq.com

Locations
Layout table for location information
China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: zhibo wen, PhD    020-61643461    zhibowen@163.com   
Sponsors and Collaborators
Zhujiang Hospital
  Study Documents (Full-Text)

Documents provided by Zhujiang Hospital:
Study Protocol  [PDF] December 27, 2019

Layout table for additonal information
Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT04945499    
Other Study ID Numbers: DGE CEST MR and brain tumor
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Zhujiang Hospital:
dynamic glucose enhanced
human brain tumor
chemical exchange saturation transfer
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases