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

November 18, 2022 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Exclusion Criteria:

  • The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with HER2 binding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 99mTc-MIRC213
99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans
Experimental: 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.
Drug: 99mTc-MIRC213
99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetric distribution of radiopharmaceuticals
Time Frame: 2 months
Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software
2 months
Standardized uptake value
Time Frame: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events collection
Time Frame: 1 year
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Zhaohui Zhu, Dr, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-MIRC213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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