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

Phase 0
18 Years
Not Enrolling
Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Metastatic Breast Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Radioiodide accumulation

Outcome Description:

To evaluate radioiodide accumulation in women with immunohistochemically NIS (Na+/I- symporter)-positive breast cancers using 124I PET/CT.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Irene L. Wapnir

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)
  • Breast Cancer Metastatic Breast Cancer
  • Breast Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary



Stanford University School of Medicine Stanford, California  94305-5317