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

NCT ID: NCT06731829

Last Updated: 2024-12-12

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

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-04-30

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HRS-9231 dose 1

Group Type EXPERIMENTAL

HRS-9231

Intervention Type DRUG

HRS-9231

HRS-9231 dose 2

Group Type EXPERIMENTAL

HRS-9231

Intervention Type DRUG

HRS-9231

HRS-9231 dose 3

Group Type EXPERIMENTAL

HRS-9231

Intervention Type DRUG

HRS-9231

Gadobutrol

Group Type ACTIVE_COMPARATOR

Gadobutrol

Intervention Type DRUG

Gadobutrol

Interventions

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HRS-9231

HRS-9231

Intervention Type DRUG

Gadobutrol

Gadobutrol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Sign the informed consent form, willing to cooperate with the study, and comply with trial requirements
2. Age ≥18 years, no gender restrictions
3. Known or highly suspected CNS lesions, with imaging showing at least one enhanced lesion
4. Scheduled for CNS contrast-enhanced MRI for clinical needs and agree to complete two contrast-enhanced MRI scans

Exclusion Criteria

1. Clinically unstable condition or severe diseases that may affect trial results, such as inability to ensure imaging comparability or reliability of study parameters
2. Moderate to severe renal dysfunction, defined as aGFR \< 60 mL/min
3. Contraindications to MRI, such as metallic implants or claustrophobia
4. History of severe allergies, including drugs, contrast agents, or other allergens
5. Severe liver disease or cardiovascular disease, or related abnormal test results
6. Central nervous system inflammation or recent history of stroke
7. Active infectious diseases, such as HIV, hepatitis B, or syphilis
8. Use of other contrast agents before or after study drug administration, or recent interventional treatments that may affect imaging comparability
9. Pregnancy, breastfeeding, or plans for conception, without effective contraception measures
10. Recent participation in other clinical trials or previous participation in studies involving gadolinium-based contrast agents
11. Other conditions deemed unsuitable by the investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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People's Hospital, Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Junpeng Zhuang

Role: CONTACT

Phone: +0518-82342973

Email: [email protected]

Other Identifiers

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HRS-9231-201

Identifier Type: -

Identifier Source: org_study_id