Clinical trial · Interventional
99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization
NCT03546478CI-TRIAL-00033218completedEarly 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-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 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-ABH2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 99mTc-ABH2 SPECT/CT
- description
- The patients were injected with 370±54 MBq of 99mTc-ABH2 in one dose intravenously and underwent SPECT/CT scan 90-270 min later.
- interventionNames
- Biological: 99mTc-ABH2
Primary outcomes (1)
- measure
- T/B
- timeFrame
- 1 year
- description
- Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer
Secondary outcomes (1)
- measure
- Adverse events collection
- timeFrame
- 1 week
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 29 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female Exclusion Criteria: Pregnancy Breastfeeding Renal function: serum creatinine \> 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance
References
Publications (0)
Data not yet available
No reference posted for this study.