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
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 28, 2021
July 1, 2021
3.1 years
March 23, 2021
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
D-glucose
OTHERDuring 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.
Interventions
using d-glucose as an contrast agent on CEST MR Imaging
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2021
First Posted
June 30, 2021
Study Start
June 1, 2019
Primary Completion
June 30, 2022
Study Completion
June 30, 2023
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share