The Application of Glucose CEST MR Imaging in Brain Tumor | NCT04945499

Studies
The Application of Glucose CEST MR Imaging in Brain Tumor

NCT04945499

Sponsor

Zhujiang Hospital

Status

Unknown status

Last Update Posted

Jul 28, 2021Actual

Enrollment

100Estimated

Phase

Early Phase 1

Conditions

Magnetic Resonance Imaging

Interventions

d-glucose

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Jun 24, 2021

First Posted Date

Jun 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2021

Last Update Posted Date

Jul 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D-glucose	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
d-glucose	Drug	using d-glucose as an contrast agent on CEST MR Imaging	D-glucose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhibo Wen, PhD	Contact	020-643461		zhibowen@163.com
Jianhua Mo, MD	Contact	15627283832		154036203@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhujiang Hospital of Southern Medical University	Recruiting	Guangzhou	Guangdong	510282	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 27, 2019	Jan 25, 2021	Prot_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

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