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Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT

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ClinicalTrials.gov Identifier: NCT00725946
Recruitment Status : Terminated
First Posted : July 31, 2008
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Irene L. Wapnir, Stanford University

Tracking Information
First Submitted Date  ICMJE July 9, 2008
First Posted Date  ICMJE July 31, 2008
Last Update Posted Date October 11, 2017
Study Start Date  ICMJE February 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Radioiodide accumulation [ Time Frame: 2 years ]
To evaluate radioiodide accumulation in women with immunohistochemically NIS (Na+/I- symporter)-positive breast cancers using 124I PET/CT.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
To determine whether radioiodide accumulation is detectable and congruent with tumor distribution on 124I PET/CT in NIS-expressing breast cancers.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Dosimetry [ Time Frame: 2 years ]
To calculate dosimetry in tumor, thyroid and whole body.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
To calculate tumor, organ and whole body dosimetry under thyroid suppressive conditions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
Official Title  ICMJE A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Cancer
  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)
  • Breast Cancer Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Iodine-124
  • Radiation: PET/CT with Iodine-124
Study Arms  ICMJE Experimental: Iodine-124 PET-CT scan
  • Drug: Iodine-124
  • Radiation: PET/CT with Iodine-124
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
Original Enrollment  ICMJE
 (submitted: July 30, 2008)
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00725946
Other Study ID Numbers  ICMJE BRS0001
98583 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-03142008-1044 ( Other Identifier: Stanford University )
IRB-11927 ( Other Identifier: Stanford Universtiy )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Irene L. Wapnir, Stanford University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Irene L. Wapnir Stanford University
PRS Account Stanford University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP