NCT00688337

Brief Summary

In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 2, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

May 28, 2008

Last Update Submit

May 30, 2008

Conditions

Breast Cancer

Keywords

Breast cancerlymph nodesgene-expressiononcotypeAge over 18Newly diagnosed breast cancer prior to surgery or treatment.No evidence of clinical nodal disease

Outcome Measures

Primary Outcomes (1)

  • Correlation between FDG and FLT uptake and hystological findings and Oncotype results

    One year after imaging

Secondary Outcomes (1)

  • Clinical outcome

    A year after imaging

Study Arms (1)

1

Patients with newly diagnosed breast cancer. Clinically nodal negative.

Eligibility Criteria

Age18 Years - 86 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed patients with breast cancer, clinically nodal negative, prior to surgery and/or treatment

You may qualify if:

  • Newly diagnosed patients with breast cancer
  • clinically nodal negative
  • prior to surgery and/or treatment
  • age over 18 years

You may not qualify if:

  • Age under 18
  • Pregnancy
  • Previous therapy for breast cancer
  • Clinical or histological evidence of nodal involvement or other proven metastatic sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Biospecimen

Retention: NONE RETAINED

not relevant

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Einat Even-Sapir, MD, PhD

CONTACT

972-3-697-3536evensap@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

June 2, 2008

Record last verified: 2008-05

Locations

IL(1)