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

Status

Completed

Conditions

Intervention / Treatment

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

  • Sweden
    • Uppland
      • 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

Biomedical Radiation Sciences

Collaborators

Swedish Cancer Society

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.

General Publications

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

Keywords

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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