99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

NCT ID: NCT05622240

Last Updated: 2022-11-21

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-07

Study Completion Date

2023-12-31

Brief Summary

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This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed Description

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99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine the use of 99mTc-MIRC213 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-MIRC213 SPECT/CT in stratifying breast cancer.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-MIRC213 Dosimetry study

about 6 patients were injected with 11.1-14 (MBq) per kilogram body weight of 99mTc-MIRC213 in one dose intravenously and underwent wholebody scan at 5min、20min、40min、60min、90min、120min、180min、240min, then analysis of dosimetric distribution of radiopharmaceuticals in human body by HERMES software.

Group Type EXPERIMENTAL

99mTc-MIRC213

Intervention Type DRUG

99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans

99mTc-MIRC213 wholebody and SPECT/CT scan

About 30 patients were injected with 11.1-14 (MBq) per kilogram body weight of 99mTc-MIRC213 in one dose intravenously and underwent wholebody scan 1 \\2\\3h later and underwent SPECT/CT scan at 2h.

Group Type EXPERIMENTAL

99mTc-MIRC213

Intervention Type DRUG

99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans

Interventions

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99mTc-MIRC213

99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans

Intervention Type DRUG

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
Maximum Eligible Age

85 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, Dr

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rongxi Wang, Dr

Role: CONTACT

+8615584172170

Zhaohui Zhu, Dr

Role: CONTACT

+8619800370331

Facility Contacts

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Zhaohui Zhu, Dr

Role: primary

+8619800370331

Other Identifiers

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PUMCH-MIRC213

Identifier Type: -

Identifier Source: org_study_id

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