HER2 Expression Detection in Breast Cancer Using 99mTc-NM-02
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|ClinicalTrials.gov Identifier: NCT04040686|
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : December 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Injection of 99mTc-NM-02||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Technetium-99m Labeled Anti-HER2 sdAb (99m-Tc-NM-02) for HER2 Expression Detection in Breast Cancer|
|Actual Study Start Date :||July 29, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Injection of 99mTc-NM-02
All breast cancer patients recruited to the study will be administered 3-12 MBq/kg of 99m-Tc-NM-02 (99m-Tc labeled anti-HER2 sdAb) in a single dose injection
Drug: Injection of 99mTc-NM-02
Patient will be injected with microdose (<100ug) of 99mTc-NM-02 radiotracer
Other Name: anti-HER2 SPECT/CT radiotracer
- Visual Assessment of HER2 expression in Breast cancer using 99mTc-NM-02 SPECT/CT Scan [ Time Frame: 1 year ]Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99m-Tc-NM-02 in breast malignant lesions. A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
- Semiquantitative Assessment of Breast and other Metastatic Lesions in 99mTc-NM-02 SPECT/CT Scan [ Time Frame: 1 year ]Each subject will be administered 3-12 MBq/kg of 99mTc-NM-02 and the semiquantitative analysis of the region of interest (ROI) will be performed in breast and other metastatic lesions. Higher level of HER2 expression (Tumor proportion score, TPS), higher ROI in tumor.
- Safety of 99mTc-NM02 through Adverse Event Monitoring [ Time Frame: 2 days ]Subjects will be observed for safety after administration of 99mTc-NM-02, and will do follow up at 48h p.i. Subjects will do blood test to observe for abnormalities in clinical parameters and compare to baseline results.
- Safety of 99m-Tc-NM-02 through Adverse Event Monitoring [ Time Frame: 7 days ]Subjects will be observed for safety after administration of 99mTc-NM-02, and will do follow up at 7d p.i. Subjects will be contacted by investigator by phone and asked several questions related to subject's health after 99m-Tc-NM-02 injection and concomitant drugs.
- HER2 Expression Heterogeneity [ Time Frame: 1 year ]Biopsy tissue sample IHC and FISH HER2 test results from subject's primary tumor will indicate its HER2 expression level, this results will be compared with our radiotracer uptake in the primary tumor and will look for heterogeneity while observing for uptake in other metastatic lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040686
|Contact: Jinhua Zhao, PhD||0086-21-63240090 ext firstname.lastname@example.org|
|Shanghai General Hospital||Recruiting|
|Shanghai, Shanghai, China, 200080|
|Contact: Jinhua Zhao, PhD 0086-21-63240090 ext 4940 email@example.com|
|Principal Investigator:||Jinhua Zhao, PhD||Shanghai General Hospital Nuclear Medicine Dept|