Integrin α6-targeted SPECT Imaging of Breast Cancer

Early Phase 1CompletedNCT04289532

Peking University9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

99mTc-RWYDRUG

99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Peking University Health Science Center

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Blood Clearance

The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.

Time frame: 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.

Time frame: 0-24 hours post-injection

Biodistribution

Area under the activity-time curve from hour 0 to last measurable activity.

Time frame: 0.5,1,2,4,24 hours post-injection

SPECT/CT imaging

Image brightness is observed。

Time frame: post-injection

Distributed in organs

The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated.

Time frame: 0.5,1,2,4,24 hours post-injection

Secondary Outcomes

Incidence of adverse events

Adverse events within 1 week after the injection and scanning were followed and assessed.

Time frame: 1 week post-injection

Data from ClinicalTrials.gov

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