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
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 breast-cancer
Started Mar 2018
Shorter than P25 for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedMarch 6, 2020
March 1, 2020
1.2 years
February 25, 2020
March 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Incidence of adverse events
1 week post-injection
Study Arms (1)
99mTc-RWY SPECT/CT
EXPERIMENTALVolunteers 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.
Interventions
99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Universitylead
- China-Japan Union Hospital, Jilin Universitycollaborator
- Sun Yat-sen Universitycollaborator
Study Sites (1)
Peking University Health Science Center
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2020
First Posted
February 28, 2020
Study Start
March 8, 2018
Primary Completion
June 1, 2019
Study Completion
June 30, 2019
Last Updated
March 6, 2020
Record last verified: 2020-03