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Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
This study is currently recruiting participants.
Verified by Stanford University, August 2009
First Received: July 9, 2008   Last Updated: August 31, 2009   History of Changes
Sponsor: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00725946
  Purpose

This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.


Condition Intervention
Breast Cancer
Procedure: 124I PET/CT

Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To determine whether radioiodide accumulation is detectable and congruent with tumor distribution on 124I PET/CT in NIS-expressing breast cancers.

Secondary Outcome Measures:
  • To calculate tumor, organ and whole body dosimetry under thyroid suppressive conditions.

Estimated Enrollment: 10
Study Start Date: February 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Stage I-IV breast cancer. Patients must have clinical or radiographic evidence of localized or metastatic disease.

2. Criteria for NIS-positivity are defined as: >= 20% of cells with plasma membrane and/or strong intracellular/plasma membrane immunoreactivity 3. Any previous therapy including radiation therapy is allowable. 4. Women 18 years of age or older. 5. Patients must have a life expectancy of at least 3 months 6. Patients with ECOG Performance Status 0-3 will be eligible. 7. If on chemotherapy, thyroid suppression should be initiated no sooner than two weeks after last chemotherapy cycle.

8. Ability to understand and willingness to sign a written informed consent document.

9. Discontinuation of hormonal or biological therapies for the 10 days of the study is preferred but not mandated.

10. Laboratory tests (CBC, comprehensive metabolic panel) must be performed within 120 day prior to study initiation.

Exclusion Criteria:1. History of metastatic thyroid cancer 2. Exclude the use of cytotoxic, hormonal or biological agents for one week prior to and during imaging.

3. Pregnant or nursing patients will be excluded from the study as iodide can accumulate in the breast and is transported across the placenta.

4. Inability to tolerate thyroid hormone and/or methimazole pre-imaging treatment.

5. History of thyroid cancer (because patient could have concomitant thyroid cancer metastases and therefore competitively concentrate radioiodides) 6. Psychiatric or addictive disorders that are not adequately controlled and would preclude obtaining informed consent.

7. Patients with heart disease or other significant cardiac risk factors will be excluded from receiving thyroid suppressive therapy so as to avoid precipitating a cardiac arrhythmia.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725946

Contacts
Contact: Marilyn Florero (650) 724-1953 florerom@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Marilyn Florero     650-724-1953     florerom@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Irene L. Wapnir            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Irene L. Wapnir Stanford University
  More Information

No publications provided

Responsible Party: Stanford University School of Medicine ( Irene L. Wapnir, Principal Investigator )
Study ID Numbers: SU-03142008-1044, 98583, BRS0001, NCT00725946
Study First Received: July 9, 2008
Last Updated: August 31, 2009
ClinicalTrials.gov Identifier: NCT00725946     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 09, 2009