CClinicalTrials.gg
RecruitingNCT06951984Updated Sep 8, 2026

Hydroxyephedrine PET/CT in Sympathetic Nervous System Disease

An observational study in Sympathetic Nervous System Diseases, Sympathetic Nervous Structure Injury and Sympathetic Nerve Injury, sponsored by Tianjin Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Tianjin Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Sympathetic Nervous System Diseases
  • Sympathetic Nervous Structure Injury
  • Sympathetic Nerve Injury

Keywords

  • PET/CT
  • MRI
  • Hydroxyephedrine
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

(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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • 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.

    Diagnostic Test: 11C/18F-HED

Interventions

  • Diagnostic test11C/18F-HED

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

05

What researchers measure

Primary outcomes

  1. Standardized uptake value (SUV)

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

    Time frame: 30 days

Secondary outcomes

  1. Diagnostic efficacy

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

    Time frame: 30 days

06

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 300052, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06951984
Lead sponsor
Tianjin Medical University
Collaborators
Tianjin Medical University General Hospital
Responsible party
Shaobo Yao, PhD (Prof., Tianjin Medical University) — Principal investigator
First posted
Apr 30, 2025
Start date
Mar 1, 2013
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Haonan Yu, MD
Contact
dreamadam@126.com
+8613821000597
Qiusong Chen, MD
Contact
qs_c8@hotmail.com
+862260362190

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion