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

NCT ID: NCT06289517

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2025-08-30

Brief Summary

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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

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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.

Conditions

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Neoplasms

Keywords

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68Ga-Her2-affibody PET/CT Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-Her2-affibody

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

Group Type EXPERIMENTAL

68Ga-Her2-affibody

Intervention Type DRUG

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

Interventions

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68Ga-Her2-affibody

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

Intervention Type DRUG

Other Intervention Names

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Her2 specific PET imaging

Eligibility Criteria

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Inclusion Criteria

\- patients with confirmed or suspected cancer; Signed written informed consent

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lei YIN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Yin, Dr

Role: CONTACT

Phone: +8610835725252

Email: [email protected]

Facility Contacts

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Lei Yin, Dr.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40338302 (View on PubMed)

Other Identifiers

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68Ga-Her2-affibody

Identifier Type: -

Identifier Source: org_study_id