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

NCT05622240 | Unknown Early Phase 1

• 1 other identifier: PUMCH-MIRC213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

SPECT/CT; HER2

Outcome Measures

Primary Outcomes (2)

• Dosimetric distribution of radiopharmaceuticals

  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

  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 Outcomes (1)

• Adverse events collection

  1 year

Study Arms (2)

99mTc-MIRC213 Dosimetry study

EXPERIMENTAL

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 wholebody and SPECT/CT scan

EXPERIMENTAL

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

Interventions

99mTc-MIRC213 DRUG

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

99mTc-MIRC213 Dosimetry study; 99mTc-MIRC213 wholebody and SPECT/CT scan

Eligibility Criteria

• Age: Up to 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhaohui Zhu, Dr

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Rongxi Wang, Dr

CONTACT

+8615584172170; zhzwrx.123@163.com

Zhaohui Zhu, Dr

CONTACT

+8619800370331; pumch_jacobwong@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 18, 2022
• Study Start: September 7, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CN (1)