Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
NCT01360177 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2016-07-20
Summary
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.
Conditions
Interventions
- PROCEDURE
-
124 PET/CT imaging
Standard of Care
- DRUG
-
Na134I
25 to 150 mCi
- DRUG
-
Tri-iodothyronine
75 ug/8hr x 4 weeks; oral
- DRUG
-
Tri-iodothyronine
20 mg/day x 2
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Irene L. Wapnir · Stanford University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2013-12-31
- Completion
- 2014-12-31
Countries
- United States
Study Locations
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