Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06690983

Tau PET/CT Imaging in Patients with Various Tau-Related Diseases

Led by Tianjin Medical University · Updated on 2025-02-11

500

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

T

Tianjin Medical University

Lead Sponsor

T

Tianjin Medical University General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the potential usefulness of 18F-S16/T807 positron emission tomography/computed tomography (PET/CT) for detecting primary and metastatic lesions in patients with various Tau-related diseases. This observational study focuses on patients with suspected, newly diagnosed, or previously treated malignant tumors related to Tauopathies and neurodegenerative diseases. The goal is to assess the diagnostic value of this imaging technique in these conditions. Participants receive a single intravenous injection of 18F-S16/T807, followed by PET/CT or MRI imaging within a specified time frame. This imaging process is used either for initial assessment or to detect recurrence of lesions. The study measures include quantifying lesion uptake by the maximum standardized uptake value (SUVmax) and calculating diagnostic accuracy parameters such as sensitivity, specificity, positive predictive value, and negative predictive value. During the study, participants undergo the imaging procedure and provide informed consent. Researchers monitor and evaluate the standardized uptake value (SUV) within 30 days as the primary outcome, while diagnostic efficacy is assessed as a secondary outcome. The study includes adults aged 18 to 80 years and involves healthy volunteers as well. The total participation time includes the imaging and assessment period within one month.

CONDITIONS

Brief Title

Tau PET/CT in Various Tau-Related Disease Patients

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Patients with suspected, newly diagnosed, or previously treated malignant tumors supported by MRI, CT, tumor markers, or pathology
  • Patients scheduled for a Tau PET/CT scan
  • Patients able to provide informed consent and assent according to ethics guidelines
Not Eligible

You will not qualify if you...

  • Patients with non-malignant lesions
  • Pregnant patients
  • Patients or their legal representatives unwilling or unable to provide written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 30 days

Participants receive a single intravenous injection of 18F-S16/T807 and undergo PET/CT or MRI imaging to assess Tau-related disease.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 30 days

Participants are observed for diagnostic efficacy and standardized uptake value outcomes up to 30 days after imaging.

Follow-up assessments as needed

Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China, 230000

Actively Recruiting

2

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China, 300052

Actively Recruiting

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Research Team

Y

Ying Wang, MD

S

Shaobo Yao, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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