NCT07130565

Brief Summary

To evaluate the potential usefulness of 18F-92/AV45/TPZA/FT8, 11C-PIB positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Pan-Amyloid-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
30mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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 Progress50%
Nov 2023Nov 2028

Study Start

First participant enrolled

November 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Keywords

PET/CTMRIPan-Amyloid

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value (SUV)

    Standardized uptake value (SUV) of 18F-92/AV45/TPZA/FT8, 11C-PIB for each target lesion of subject or suspected Pan-Amyloid related diseases.

    30 days

Secondary Outcomes (1)

  • Diagnostic efficacy

    30 days

Study Arms (1)

Single Group Assignment

Each subject receive a single intravenous injection of 18F-92/AV45/TPZA/FT8, 11CPIB and undergo PET/CT or MRI imaging within the specificed time.

Diagnostic Test: 18F-92/AV45/TPZA/FT8, 11CPIB

Interventions

Each subject receive a single intravenous injection of 18F-92/AV45/TPZA/FT8, 11C-PIB 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 CA (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled amyloid 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 cardiac amyloidosis (supporting evidence may include MRI, CT, serum markers and pathology report); (iii) patients who had scheduled Pan-Amyloid 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-CA 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 (2)

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

Hefei, Anhui, 230000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 350005, China

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseAmyloid Neuropathies, FamilialAmyloidosis

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersHeredodegenerative Disorders, Nervous SystemAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesProteostasis Deficiencies

Central Study Contacts

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

August 12, 2025

First Posted

August 19, 2025

Study Start

November 1, 2023

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations