PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression
A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors
1 other identifier
interventional
30
1 country
1
Brief Summary
This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedStudy Start
First participant enrolled
May 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2025
CompletedDecember 18, 2024
December 1, 2024
1.2 years
February 25, 2024
December 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer
the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT
1 year
Secondary Outcomes (3)
The dosimetry of 68Ga-Her2-affibody
1 year
Quantitative evaluation of 68Ga-Her2-affibody
1 year
Correlation with pathological expression
1 year
Study Arms (1)
68Ga-Her2-affibody
EXPERIMENTALSubjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging.
Interventions
68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Eligibility Criteria
You may qualify if:
- \- patients with confirmed or suspected cancer; Signed written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Related Publications (1)
Gao Y, Yin L, Duan X, Fu Z, Liu Q, Chen J, Xin L, Zhu X, Xiang H, Xu L, Ye J, Liu M. HER2-targeted PET/CT imaging provides potential biomarkers for differentiating HER2-zero, -low, and -positive breast cancer. Eur J Nucl Med Mol Imaging. 2025 Oct;52(12):4525-4538. doi: 10.1007/s00259-025-07220-3. Epub 2025 May 8.
PMID: 40338302DERIVED
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 25, 2024
First Posted
March 4, 2024
Study Start
May 28, 2024
Primary Completion
July 30, 2025
Study Completion
August 30, 2025
Last Updated
December 18, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share