99mTc-ABH2 SPECT/CT in Breast Cancer

NCT ID: NCT06194565

Last Updated: 2024-01-08

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2024-01-30

Brief Summary

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This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.

Detailed Description

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This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.

Conditions

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Breast Cancer

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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99mTc-ABH2 SPECT/CT

The patients will be injected with 5.55 to 7.4 MBq per kilogram body weight of 99mTc-ABH2 in one dose intravenously and undergo SPECT/CT scan 1h to 2h later.

Group Type EXPERIMENTAL

99mTc-ABH2

Intervention Type DRUG

Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.

Interventions

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99mTc-ABH2

Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form

Exclusion Criteria

* pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongli MD Jing

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuwei Zhang

Role: CONTACT

+8618511071577

Hongli MD Jing

Role: CONTACT

Facility Contacts

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Hongli Jing

Role: primary

Other Identifiers

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PUMCH-ABH2

Identifier Type: -

Identifier Source: org_study_id

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