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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 99mTc-RWY SPECT/CT; 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; 99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .; Other Names: 99mTc-labeled peptide targeting integrin α6

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Sun Yat-sen University; China-Japan Union Hospital, Jilin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2018
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; SPECT; integrin α6
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 010006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No