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NCT Number: NCT06951984

Hydroxyephedrine PET/CT in Sympathetic Nervous System Disease

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.

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Key information

Conditions

Sympathetic Nervous System Diseases Autonomic Nervous System Diseases Nervous System Diseases Sympathetic Nerve Injury Sympathetic Nervous Structure Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location status: Recruiting

Location contact

Haonan Yu, MD

CONTACT

[email protected]

+8613821000597

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

11C/18F-HED

Diagnostic Test

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

Primary outcomes

  1. Standardized uptake value (SUV)

    Time frame: 30 days

    Standardized uptake value (SUV) of 11C/18F-HED for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary outcomes

  1. Diagnostic efficacy

    Time frame: 30 days

    The sensitivity, specificity and accuracy of HED PET/CT were calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Haonan Yu, MD

CONTACT

[email protected]

+8613821000597

Qiusong Chen, MD

CONTACT

[email protected]

+862260362190

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Official study title

Hydroxyephedrine PET/CT in Sympathetic Nervous System Diseases

Important dates

Study start
2013
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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