A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
December 9, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over, Dose-Escalation Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to explore the effective dose of HRS-9231 for CNS MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
78
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junpeng Zhuang
- Phone Number: +0518-82342973
- Email: junpeng.zhuang.jz5@hengrui.com
Study Locations
-
-
Beijing
-
Peking, Beijing, China, 100000
- People's Hospital, Peking University
-
Principal Investigator:
- Nan Hong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements
- Age ≥18 years, no gender restrictions
- Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion
- Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans
Exclusion Criteria:
- Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters
- Moderate to severe renal dysfunction, defined as aGFR < 60 mL/min
- Contraindications to MRI, such as metallic implants or claustrophobia
- History of severe allergies, including drugs, contrast agents, or other allergens
- Severe liver disease or cardiovascular disease, or related abnormal test results
- Central nervous system inflammation or recent history of stroke
- Active infectious diseases, such as HIV, hepatitis B, or syphilis
- Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability
- Pregnancy, breastfeeding, or plans for conception, without effective contraception measures
- Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents
- Other conditions deemed unsuitable by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HRS-9231 dose 1
|
HRS-9231
|
|
Experimental: HRS-9231 dose 2
|
HRS-9231
|
|
Experimental: HRS-9231 dose 3
|
HRS-9231
|
|
Active Comparator: Gadobutrol
|
Gadobutrol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol)
Time Frame: 1 day procedure
|
1 day procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).
Time Frame: 1 day procedure
|
1 day procedure
|
|
Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.
Time Frame: 1 day procedure
|
1 day procedure
|
|
Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement.
Time Frame: 1 day procedure
|
1 day procedure
|
|
HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).
Time Frame: 1 day procedure
|
1 day procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
December 9, 2024
First Posted (Estimated)
December 12, 2024
Study Record Updates
Last Update Posted (Estimated)
December 12, 2024
Last Update Submitted That Met QC Criteria
December 9, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HRS-9231-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.