99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer

NCT ID: NCT04267900

Last Updated: 2022-09-14

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-07

Study Completion Date

2020-12-31

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-HPArk2 in breast cancer patients. A single dose of 11.1Mega-Becquerel (MBq) per kilogram body weight 99mTc-HPArk2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed Description

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99mTc-HPArk2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-HPArk2 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-HPArk2 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-HPArk2 SPECT/CT

The patients were injected with 11.1 (MBq) per kilogram body weight of 99mTc-HPArk2 in one dose intravenously and underwent SPECT/CT scan 30-60 min later.

Group Type EXPERIMENTAL

99mTc-HPArk2

Intervention Type DRUG

99mTc-HPArk2 were injected into the patients before the SPECT/CT scans

Interventions

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99mTc-HPArk2

99mTc-HPArk2 were injected into the patients before the SPECT/CT scans

Intervention Type DRUG

Other Intervention Names

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99mTc labelled HER2 affibody

Eligibility Criteria

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Inclusion Criteria

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form
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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Zhaohui Zhu, MD,PHD

Role: STUDY_CHAIR

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

Locations

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

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Shi J, Du S, Wang R, Gao H, Luo Q, Hou G, Zhou Y, Zhu Z, Wang F. Molecular imaging of HER2 expression in breast cancer patients using a novel peptide-based tracer 99mTc-HP-Ark2: a pilot study. J Transl Med. 2023 Jan 11;21(1):19. doi: 10.1186/s12967-022-03865-y.

Reference Type DERIVED
PMID: 36631812 (View on PubMed)

Other Identifiers

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PekingUMCH-NM25

Identifier Type: -

Identifier Source: org_study_id

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