NCT01216033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

October 6, 2010

Last Update Submit

April 12, 2013

Conditions

Breast Cancer

Keywords

Breast cancerDiagnosticsHER2ImagingMetastasesSPECTImaging of metastases

Outcome Measures

Primary Outcomes (1)

  • Imaging of metastases

    Imaging of breast cancer metastases using 111-In-ABY015 for SPECT

    One year

Secondary Outcomes (1)

  • Can the new molecule be used for imaging in extended studies

    October 2010 - June 2011

Interventions

111-In-ABY-025DRUG

Intravenous injection of the agent

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female age \>20 years
  • one or more known metastases localizations

You may not qualify if:

  • other critical disease than breast cancer
  • age ≤ 20 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademiska Hospital

Uppsala, Uppland, SE75185, Sweden

Location

Related Publications (1)

  • Carlsson J, Nordgren H, Sjostrom J, Wester K, Villman K, Bengtsson NO, Ostenstad B, Lundqvist H, Blomqvist C. HER2 expression in breast cancer primary tumours and corresponding metastases. Original data and literature review. Br J Cancer. 2004 Jun 14;90(12):2344-8. doi: 10.1038/sj.bjc.6601881.

    PMID: 15150568BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

SE(1)