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
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Cancer Metastatic Breast Cancer||Drug: Iodine-124 Radiation: PET/CT with Iodine-124||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
|Experimental: Iodine-124 PET-CT scan||
Radiation: PET/CT with Iodine-124
- 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.
- Dosimetry [ Time Frame: 2 years ]To calculate dosimetry in tumor, thyroid and whole body.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725946
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Irene L. Wapnir||Stanford University|
|Responsible Party:||Irene L. Wapnir, Associate Professor, Stanford University|
|Other Study ID Numbers:||
98583 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-03142008-1044 ( Other Identifier: Stanford University )
IRB-11927 ( Other Identifier: Stanford Universtiy )
|First Posted:||July 31, 2008 Key Record Dates|
|Last Update Posted:||October 11, 2017|
|Last Verified:||October 2017|
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