The Application of Glucose CEST MR Imaging in Brain Tumor

NCT ID: NCT04945499

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Magnetic Resonance Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

d-glucose

Intervention Type DRUG

using d-glucose as an contrast agent on CEST MR Imaging

Interventions

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d-glucose

using d-glucose as an contrast agent on CEST MR Imaging

Intervention Type DRUG

Other Intervention Names

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50% dextrose injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhibo Wen, PhD

Role: CONTACT

020-643461

Jianhua Mo, MD

Role: CONTACT

15627283832

Facility Contacts

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zhibo wen, PhD

Role: primary

020-61643461

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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DGE CEST MR and brain tumor

Identifier Type: -

Identifier Source: org_study_id

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