Integrin α6-targeted SPECT Imaging of Breast Cancer

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: 99mTc-RWY

• Registration Number: NCT04289532
• Lead Sponsor: Peking University

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.

Study Timeline

• Study Start: 2018-03-08
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-30
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-RWY SPECT/CT	99mTc-RWY	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Peking University Health Science Center; 🇨🇳 Beijing, Beijing, China