Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
Information source: Stanford University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: 124I PET/CT (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Irene L. Wapnir, Principal Investigator, Affiliation: Stanford University
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.
Clinical Details
Official title: A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
Study design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: To determine whether radioiodide accumulation is detectable and congruent with tumor distribution on 124I PET/CT in NIS-expressing breast cancers.
Secondary outcome: To calculate tumor, organ and whole body dosimetry under thyroid suppressive conditions.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Marilyn Florero, Phone: 650-724-1953, Email: florerom@stanford.edu
Cancer Clinical Trials Office, Phone: (650) 498-7061
Irene L. Wapnir, Principal Investigator
Additional Information
Last updated: August 8, 2008
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