A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

NCT06731829 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-9231-201
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions

Outcome Measures

Primary Outcomes (1)

• 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)

  1 day procedure

Secondary Outcomes (4)

• Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol).

  1 day procedure

• Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug.

  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.

  1 day procedure

• HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.).

  1 day procedure

Study Arms (4)

HRS-9231 dose 1

EXPERIMENTAL

Drug: HRS-9231

HRS-9231 dose 2

EXPERIMENTAL

Drug: HRS-9231

HRS-9231 dose 3

EXPERIMENTAL

Drug: HRS-9231

Gadobutrol

ACTIVE COMPARATOR

Drug: Gadobutrol

Interventions

HRS-9231 DRUG

HRS-9231

HRS-9231 dose 1; HRS-9231 dose 2; HRS-9231 dose 3

Gadobutrol DRUG

Gadobutrol

Gadobutrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

People's Hospital, Peking University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

gadobutrol

Central Study Contacts

Junpeng Zhuang

CONTACT

+0518-82342973; junpeng.zhuang.jz5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)