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Scintigraphic Assessment of I- Transport in Metastatic Breast Cancer and Evaluation of I31I Ablative Therapy: (Part I) Radioiodide Imaging Study

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185809
First received: September 12, 2005
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to examine breast cancers that express the protein (NIS) that may be found in malignant breast tissues and to evaluate proteins found in blood and their relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive iodine entering breast cancer cells, how long your cancer retains the agent as well as how much is taken up by other organs, particularly the thyroid gland.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Scintigraphic Assessment of I- Transport in Metastatic Breast Cancer and Evaluation of I31I Ablative Therapy: (Part I) Radioiodide Imaging Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Biospecimen Retention:   Samples Without DNA

Archival tissue blocks and blood


Estimated Enrollment: 25
Study Start Date: November 2000
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

To demonstrate iodide uptake capacity of breast cancer metastases by imaging women with iodide radioisotope (123I) and calculating potential ablative dose of radioactive iodide (131I).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligibility criteria include histological proof of invasive breast cancer and current radiological evidence of metastatic disease.

Criteria

Inclusion Criteria:- Only women diagnosed with breast cancer

  • 18 years of age or older
  • From whom informed consent can be obtained
  • Patient is able to provide a fluid (e.g. cyst fluid)
  • Patient with blood test that shows protein may allow iodide to accumulate in breast tissue
  • Patient who's breast cancer cells accumulated I123 and held on to it for 24 hours

Exclusion Criteria:- Males

- Children

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185809

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Irene L. Wapnir Stanford University
  More Information

No publications provided

Responsible Party: Irene L. Wapnir, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185809     History of Changes
Other Study ID Numbers: BRSMTS0002, 75632, BRSMTS0002, NIH
Study First Received: September 12, 2005
Last Updated: July 16, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013