An interventional study of 124 PET/CT imaging and Na134I in Breast Cancer and Metastatic Breast Cancer, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
Procedure: 124 PET/CT imaging · Drug: Na134I · Drug: Tri-iodothyronine
Standard of Care
Also known as: Positron emission tomography - computed tomography
25 to 150 mCi
Also known as: GE Healthcare
75 ug/8hr x 4 weeks; oral
Also known as: T3
20 mg/day x 2
Also known as: T3
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
* cCR (complete clinical response) = disappearance of all tumor * cPR (clinical partial response) = \>=30% decrease sum of longest target lesion diameters * cPD (progressive disease) = \>=20% increase sum of longest target lesion diameters. * cSD (stable disease) = small changes that do not meet these criteria
Time frame: 6 WEEKS POST-TREATMENT
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
* Complete Response (CR): Disappearance of all non-target lesions * Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesions(s) * Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Time frame: EVALUATED AT 6 WEEKS
This study is withdrawn, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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