NCT07368036

Brief Summary

The purpose of this clinical trial is to use the medical magnetic resonance imaging system MR 7700 to perform phosphorus (31P) and sodium (23Na) scanning imaging on the human body, evaluate the image quality of phosphorus (31P) and sodium (23Na) scanning, as well as the machine convenience, machine stability, and system safety of the entire system.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

December 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 1, 2025

Last Update Submit

January 20, 2026

Conditions

Image QualityDevice ConvenienceDevice StabilitySystem SafetyMR Multinuclear

Keywords

multinuclearMR

Outcome Measures

Primary Outcomes (2)

  • The excellent and good rate of Spectral image quality of 31P-MRS

    Spectral image quality of phosphorus nucleus (31P) in each site (muscle, liver, heart)，will be assessed by Likert score (1-5) . The final evaluation of image quality at 3 points or above is considered excellent and good.The rate of excellent and good should be over 75%.

    14 days (anticipated) after finishing 31P-MRS scanning

  • The excellent and good rate of image quality of 23Na-MRI

    Image quality of sodium nuclei (23Na) in each site (liver, cartilage), will be assessed by Likert score (1-5) . The final evaluation of image quality at 3 points or above is considered excellent and good.The rate of excellent and good should be over 75%.

    14 days (anticipated) after finishing 23Na-MRI scanning

Secondary Outcomes (4)

  • The Device convenience of the entire system

    14 days (anticipated) after finishing scanning

  • Device stability

    14 days (anticipated) after finishing scanning

  • System security

    14 days (anticipated) after finishing scanning

  • Adverse event

    From the time the subjects signed the ICF to completion of study visit(1 day).

Study Arms (2)

Healthy volunteers

EXPERIMENTAL
Device: MR Scanning with Phosphorus nucleus + Sodium nucleus

Patient

EXPERIMENTAL
Device: MR Scanning with Phosphorus nucleus + Sodium nucleus

Interventions

MR Scanning with Phosphorus nucleus + Sodium nucleusDEVICE

Using the Magnetic Resonance Equipment to perform phosphorus nucleus (31P) and sodium nucleus (23Na) scanning

Healthy volunteersPatient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 18 ≤ Age ≤ 75 years old;
  • Clear mind, able to cooperate, and capable of autonomous behavior;
  • Voluntarily agree to participate in this clinical trial and sign the informed consent form for the subjects

You may not qualify if:

  • Individuals with claustrophobia.
  • On the day of scanning, the subject's body temperature was above 39.5 ℃.
  • Plan to become pregnant, pregnant, and breastfeeding women within 6 months.
  • Other implants, prostheses, foreign bodies, patches, etc. that are not suitable for magnetic resonance imaging examination; There are electronic implants such as pacemakers, stimulators, insulin pumps, cochlear implants, etc.
  • Critical patients equipped with various rescue devices, as well as subjects with any emergency medical conditions requiring first aid.
  • Subjects with poor compliance, which the researchers believe should be excluded.
  • Other situations that the investigators believe are not suitable for participating in this experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Bing Zhang

CONTACT

(+86)15851803070zhangbing_nanjing@vip.163.com

Andi Gao

CONTACT

(+86)13601250646Andi.Gao@Philips.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

January 26, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01