NCT06951984

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Mar 2013Mar 2028

Study Start

First participant enrolled

March 1, 2013

Completed
12.2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

15 years

First QC Date

April 23, 2025

Last Update Submit

April 23, 2025

Conditions

Keywords

PET/CTMRIHydroxyephedrine

Outcome Measures

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.

    30 days

Secondary Outcomes (1)

  • Diagnostic efficacy

    30 days

Study Arms (1)

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

11C/18F-HEDDIAGNOSTIC_TEST

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

Single Group Assignment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Qiusong Chen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 23, 2025

First Posted

April 30, 2025

Study Start

March 1, 2013

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations