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| ID | Type | Description | Link |
|---|---|---|---|
| SU-07292008-1271 | Other Identifier | Stanford University | |
| 14941 | Other Identifier | Stanford IRB |
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This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS [Na+I- symporter, sodium iodide symporter] and demonstrate radioiodide uptake on 124I PET/CT scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25 to 100 mCi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radioactive Iodide and PET/CT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 124 PET/CT imaging | Procedure | Standard of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response |
| 6 WEEKS POST-TREATMENT |
| Measure | Description | Time Frame |
|---|---|---|
| Non target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene L. Wapnir | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014284 | Triiodothyronine |
| ID | Term |
|---|---|
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Na134I | Drug | 25 to 150 mCi |
|
|
| Tri-iodothyronine | Drug | 75 ug/8hr x 4 weeks; oral |
|
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| Tri-iodothyronine | Drug | 20 mg/day x 2 |
|
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| EVALUATED AT 6 WEEKS |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013974 | Thyroxine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |