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NCT06289517 Clinical Trial

PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression

Neoplasms Clinical Trial

Official title:
A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06289517
Other study ID # 68Ga-Her2-affibody
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date June 30, 2025

Study information
Verified date February 2024
Source Peking University First Hospital
Contact Lei Yin, Dr
Phone +8610835725252
Email jack-yin@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date June 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with confirmed or suspected cancer; Signed written informed consent Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Ga-Her2-affibody
68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Locations
Country Name City State
China Peking University First Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The dosimetry of 68Ga-Her2-affibody Research on the dose distribution of 68Ga-Her2-affibody in cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software 1 year
Secondary Quantitative evaluation of 68Ga-Her2-affibody Analyze Her2 expression at the imaging level in combination with Her2 expression 1 year
Secondary Correlation with pathological expression Analyze Her2 expression at the imaging level in combination with Her2 expression in pathological specimens 1 year
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