Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with measurable locally advanced or metastatic breast cancer who completed 124I PET/CT imaging study.
- •Patients who are 18 years of age or older.
- •Patients must have a life expectancy of at least 3 months.
- •I 124 dosimetry completed with thyroid dose to 500 cGy or less and tumor dose of 2500 cGy or more.
- •I131 therapeutic dose calculated from dosimetry. Dose must be in a range of 25 to 150 mCi.
- •Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 will be eligible.
- •Use of concurrent systemic therapy (hormonal or cytotoxic) if associated with stable disease for at least three months prior to treatment.
- •Women with locally advanced breast cancer and simultaneous metastases, even if surgery to eradicate local disease has taken place.
- •Thyroid stimulating hormone (TSH) must be < 0.4 uIU/mL.
- •White blood cell count >= 1,500 and platelet count >= 40,000
- •Women receiving thyroid hormone supplements and methimazole.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Premenopausal women must use contraception while receiving this treatment and during follow-up period of 42 days.
排除标准
- •Stage 0-II breast cancer.
- •Pregnant or nursing women.
- •Not able to sign informed consent.
- •Untreated psychiatric disorder.
- •Women who have not had I124 PET/CT scan and dosimetry calculations.
- •Radioiodide uptake in non-target organs or bone marrow does not exceed 25 cGy by pre-treatment dosimetry.
- •Received chemotherapy less than 4 weeks before.
- •History of thyroid cancer.
研究组 & 干预措施
Radioactive Iodide and PET/CT
干预措施: 124 PET/CT imaging (Procedure)
Radioactive Iodide and PET/CT
干预措施: Na134I (Drug)
Radioactive Iodide and PET/CT
干预措施: Tri-iodothyronine (Drug)
结局指标
主要结局
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
时间窗: 6 WEEKS POST-TREATMENT
* 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
次要结局
- 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(EVALUATED AT 6 WEEKS)