99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

NCT ID: NCT03546478

Last Updated: 2018-06-06

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

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-24

Study Completion Date

2018-05-18

Brief Summary

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This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed Description

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99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-ABH2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-ABH2 SPECT/CT in stratifying breast cancer.

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 were injected with 370±54 MBq of 99mTc-ABH2 in one dose intravenously and underwent SPECT/CT scan 90-270 min later.

Group Type EXPERIMENTAL

99mTc-ABH2

Intervention Type BIOLOGICAL

99mTc-ABH2 were injected into the patients before the SPECT/CT scans

Interventions

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99mTc-ABH2

99mTc-ABH2 were injected into the patients before the SPECT/CT scans

Intervention Type BIOLOGICAL

Other Intervention Names

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99mTc labelled HER2 affibody

Eligibility Criteria

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Inclusion Criteria

Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female

Exclusion Criteria

Pregnancy Breastfeeding Renal function: serum creatinine \> 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance
Minimum Eligible Age

29 Years

Maximum Eligible Age

76 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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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Fang Li, MD

Role: STUDY_CHAIR

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical Colleg

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CaiJ

Identifier Type: -

Identifier Source: org_study_id

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