Integrin α6-targeted SPECT Imaging of Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.

Official Title
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First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: 99mTc-RWY


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-RWY SPECT/CT<br>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. | Drug: 99mTc-RWY<br>* 99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .<br>* Other names: 99mTc-labeled peptide targeting integrin α6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Clearance | The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated. | 1,3,5,10,15,30,60,120 minutes post-injection | 
| Excretion | The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated. | 0-24 hours post-injection | 
| Biodistribution | Area under the activity-time curve from hour 0 to last measurable activity. | 0.5,1,2,4,24 hours post-injection | 
| SPECT/CT imaging | Image brightness is observed。 | post-injection | 
| Distributed in organs | The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated. | 0.5,1,2,4,24 hours post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Adverse events within 1 week after the injection and scanning were followed and assessed. | 1 week post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, integrin α6, SPECT