99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer
1 other identifier
interventional
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 breast-cancer
Started Dec 2019
Shorter than P25 for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2019
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 14, 2022
September 1, 2022
1.1 years
February 11, 2020
September 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardized uptake value of 99mTc-HPArk2 in breast tumor
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.
1 year
Secondary Outcomes (1)
Adverse events collection
1 week
Study Arms (1)
99mTc-HPArk2 SPECT/CT
EXPERIMENTALThe 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.
Interventions
99mTc-HPArk2 were injected into the patients before the SPECT/CT scans
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
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.
PMID: 36631812DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaohui Zhu, MD,PHD
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 13, 2020
Study Start
December 7, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
September 14, 2022
Record last verified: 2022-09