- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01216033
Exploratory Study of Breast Cancer With ABY025 (ABY0125)
April 12, 2013 updated by: Biomedical Radiation Sciences
An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer
The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding molecule 111-In-ABY025 and if that shows whether the metastases express HER2.
Study Overview
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uppland
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Uppsala, Uppland, Sweden, SE75185
- Akademiska hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female age >20 years
- one or more known metastases localizations
Exclusion Criteria:
- other critical disease than breast cancer
- age ≤ 20 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging of metastases
Time Frame: One year
|
Imaging of breast cancer metastases using 111-In-ABY015 for SPECT
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Can the new molecule be used for imaging in extended studies
Time Frame: October 2010 - June 2011
|
October 2010 - June 2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
October 6, 2010
First Submitted That Met QC Criteria
October 6, 2010
First Posted (Estimate)
October 7, 2010
Study Record Updates
Last Update Posted (Estimate)
April 15, 2013
Last Update Submitted That Met QC Criteria
April 12, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111InABY025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Gilead SciencesCompleted