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Hydroxyephedrine PET/CT in Sympathetic Nervous System Disease

NCT ID: NCT06951984

Last Updated: 2025-04-30

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

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-01

Study Completion Date

2028-03-01

Brief Summary

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To evaluate the potential usefulness of 11C/18F-HED positron emission tomography/ computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.

Detailed Description

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Subjects with various sympathetic nerves-related disease patients underwent 11C/18F-HED PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 11C/18F-HED PET/CT were calculated.

Conditions

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Sympathetic Nervous System Diseases Sympathetic Nervous Structure Injury Sympathetic Nerve Injury

Keywords

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PET/CT MRI Hydroxyephedrine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Group Assignment

Each subject receive a single intravenous injection of 11C/18F-HED and undergo PET/CT or MRI imaging within the specificed time.

11C/18F-HED

Intervention Type DIAGNOSTIC_TEST

Each subject receive a single intravenous injection of 11C/18F-HED and undergo PET/CT or MRI imaging within the specificed time.

Interventions

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11C/18F-HED

Each subject receive a single intravenous injection of 11C/18F-HED and undergo PET/CT or MRI imaging within the specificed time.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled HED PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shaobo Yao, PhD

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haonan Yu, MD

Role: CONTACT

Phone: +8613821000597

Email: [email protected]

Qiusong Chen, MD

Role: CONTACT

Phone: +862260362190

Email: [email protected]

Facility Contacts

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Haonan Yu, MD

Role: primary

Other Identifiers

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TJMUGH-10

Identifier Type: -

Identifier Source: org_study_id