Spectral CT Clinical Trial Protocol

NCT ID: NCT05017233

Last Updated: 2024-05-17

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

TERMINATED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2023-02-12

Brief Summary

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The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT

Detailed Description

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Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.

Conditions

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CT Scanning

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental group, all volunteer will be scanned.

All participation accept Spectral CT scanning; No group;

Group Type EXPERIMENTAL

Spectral CT

Intervention Type DEVICE

Using Spectral CT to scan Breast

Interventions

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Spectral CT

Using Spectral CT to scan Breast

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Recruit volunteers (ages 18 to 75);
* Negative pregnancy tests in women of childbearing age;
* Participants who agree to participate in this clinical trial and sign the informed consent;
* Enhanced scans require laboratory tests to confirm normal renal function.

Exclusion Criteria

* Persons who do not have full capacity for civil conduct;
* Lactating women;
* People who are not suitable for enhanced scanning with iodine contrast agent;
* Patients whom the investigator considers inappropriate to participate in this clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Philips (China) Investment CO., LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiyuan Liu, Director

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Fuhua Yan, Director

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Bin Song, Director

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Ruijin Hospital

Shanghai, , China

Site Status

Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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PD_CT_Hawk_2021_11258

Identifier Type: -

Identifier Source: org_study_id

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