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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04289532

Enrollment

Registered

2020-02-28

Start date

2018-03-08

Completion date

2019-06-30

Last updated

2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, integrin α6, SPECT

Brief summary

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

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.

Interventions

DRUG99mTc-RWY

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026