Integrin α6-targeted SPECT Imaging of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289532
• Other study ID #: 010006
• Status: Completed
• Phase: Early Phase 1
• Start date: March 8, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2020
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Peking University Health Science Center	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University	China-Japan Union Hospital, Jilin University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Excretion	The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.	0-24 hours post-injection
Primary	Biodistribution	Area under the activity-time curve from hour 0 to last measurable activity.	0.5,1,2,4,24 hours post-injection
Primary	SPECT/CT imaging	Image brightness is observed?	post-injection
Primary	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	Incidence of adverse events	Adverse events within 1 week after the injection and scanning were followed and assessed.	1 week post-injection