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

Peking University

Status: Enrolling

Conditions: Neoplasms

Treatments: Drug: 68Ga-Her2-affibody

Study type: Interventional

Funder types: Other

Identifiers

NCT06289517

68Ga-Her2-affibody

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with confirmed or suspected cancer; Signed written informed consent

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

68Ga-Her2-affibody

Experimental group

Description:

Subjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging.

Treatment:

Drug: 68Ga-Her2-affibody