Expired Study
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Stanford, California 94305


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.


Study summary:

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).


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


Study is Available At:


Original ID:

BRSMTS0002


NCT ID:

NCT00185809


Secondary ID:

75632


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

25


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Irene L. Wapnir
Principal Investigator
Stanford University

Study Dates

Start Date:November 2000
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:July 2010
Last Changed Date:July 16, 2010
First Received Date:September 12, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Susan G. Komen Breast Cancer Foundation

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Archival tissue blocks and blood
Study Population: Eligibility criteria include histological proof of invasive breast cancer and current radiological evidence of metastatic disease.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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