Clinical trial · Interventional
99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer
NCT04267900CI-TRIAL-00060845completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-HPArk2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 99mTc-HPArk2 SPECT/CT
- description
- The 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.
- interventionNames
- Drug: 99mTc-HPArk2
Primary outcomes (1)
- measure
- Standardized uptake value of 99mTc-HPArk2 in breast tumor
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (1)
- measure
- Adverse events collection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShi 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 36631812