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

NCT ID: NCT06289517

Condition: Neoplasms

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
68Ga-Her2-affibody
PET/CT
Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68Ga-Her2-affibody
Description: 68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Arm group label: 68Ga-Her2-affibody

Other name: Her2 specific PET imaging

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.

Detailed 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients with confirmed or suspected cancer; Signed written informed consent Exclusion Criteria: -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Contact:
Last name: Lei Yin, Dr.

Phone: +861083575252
Email: jack-yin@163.com

Start date: April 1, 2024

Completion date: June 30, 2025

Lead sponsor:
Agency: Peking University First Hospital
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06289517

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