Clinical trial · Interventional
Integrin α6-targeted SPECT Imaging of Breast Cancer
First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer
NCT04289532CI-TRIAL-00043854completedEarly 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)
A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.
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-RWY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 99mTc-RWY SPECT/CT
- description
- Volunteers and patients were injected intravenously with 11.1 MBq/kg of 99mTc-RWY in one dose and underwent SPECT/CT scan 30-60 min later.
- interventionNames
- Drug: 99mTc-RWY
Primary outcomes (5)
- measure
- Blood Clearance
- timeFrame
- 1,3,5,10,15,30,60,120 minutes post-injection
- description
- The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.
- measure
- Excretion
- timeFrame
- 0-24 hours post-injection
- description
- The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion criteria: * Healthy volunteers. * Body mass index (BMI) at 19 to 25 \[Body mass index = body weight (kg)/ height squared (m2)\]; * Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance; * Informed written consents were obtained from all 9 subjects before the procedure. * Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information. Exclution Criteria: • The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.
References
Publications (0)
Data not yet available
No reference posted for this study.