AmyloidNCT06725706
Beta Amyloid PET/CT in Various Aβ-Related Disease
An observational study of Amyloid and Beta-Amyloid, run by Tianjin Medical University at 4 sites in China.
Trial summary
To evaluate the potential usefulness of 18F-92/AV45, 11C-PIB positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyloid, Beta-Amyloid, Neurodegenerative Diseases
- What is being tested?
- 18F-92/AV45, 11C-PIB
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 4 sitesChina
- Study dates
- 1 Sep 2012to 1 Dec 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 Aβ 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.
Who may be able to join
- (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 Aβ 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.
Who cannot join
- (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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Chinese PLA General Hospital,
Beijing, Beijing Municipality, 100853
Yan Chang, MD, +8618210830630, cyneurology@163.com
Yan Chang, MD
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
Qiang Xie, PhD, +8613721108043, ahxq1980@163.com
Qiang Xie, PhD
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Guangjie Yang, MD, +8617853297979, ygj_2815@qdu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Ying Wang, MD, +8618702292537, macrossplusvoices@163.com
About this study
To evaluate the potential usefulness of 18F-92/AV45, 11C-PIB 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 Tau-related disease patients underwent 18F-92/AV45, 11C-PIB 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 18F-92/AV45, 11C-PIB PET/CT were calculated.
- Conditions
- Amyloid, Beta-Amyloid, Neurodegenerative Diseases
- Being tested
- 18F-92/AV45, 11C-PIB
- Keywords
- PET/CT, MRI, Beta-Amyloid
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-92/AV45, 11C-PIBDiagnostic test
Each subject receive a single intravenous injection of 18F-92/AV45, 11C-PIB and undergo PET/CT or MRI imaging within the specificed time.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Each subject receive a single intravenous injection of 18F-92/AV45, 11C-PIB and undergo PET/CT or MRI imaging within the specificed time. Receives: Diagnostic Test: 18F-92/AV45, 11C-PIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 18F-92/AV45, 11C-PIB for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: 30 days
Secondary outcomes (1)
Diagnostic efficacy
The sensitivity, specificity and accuracy of Aβ PET/CT were calculated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Sep 2012
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmyloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Shaobo Yao, PhD, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725706
- Sponsor's protocol ID
- TJMUGH-07
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Pan M, Yu H, Zhang Q, Chang Y, Zhao H, Wang J, Wang X, Dai J, Yu L, Chen D, Zhang J, Yan XX, Yao S, Cui M. Preclinical and preliminary clinical evaluation of [18F]Florbetazine for non-invasive PET detection of cardiac amyloidosis. Eur J Nucl Med Mol Imaging. 2026 Apr;53(5):3364-3374. doi: 10.1007/s00259-025-07719-9. Epub 2026 Jan 10.
PubMed 41518400