Immuno gamma scanning with 99mTc-marked 14F7 MaB in patients with metastatic breast tumor

Center of Molecular Inmunology (CIM)0 个研究点目标入组 21 人开始时间: 2008年12月27日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Diagnostic

•1) Patients giving their consent in writing to participate in the clinical trial. 2) Patients with breast carcinoma, phase IV upon diagnosis, or evolving metastatic disease, with cyto-histological confirmation of base disease and of metastasis by imaging and cyto-histological tests. 3) Patients aged 18 to 80. 4) Patients whose general condition is lower than or equal to 2 under WHO criteria. 5) Preserved kidney function with creatinine values within normal limits (35-132 mmol/L). 6) Patients with hemoglobin values over 10g/L, leucocytes over 4,000/mm3, platelets 100 x 109, and transaminase and alkaline phosphatase up to 2.5 times higher than normal reference values. 7) Female patients will be included in the study.

•1) Pregnancy and breastfeeding. 2) Reproductive-age patients not using contraceptive methods. 3) Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.5oC). 4) Patients with history of uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis, and high blood pressure. 5) Patients with allergic conditions or history of severe allergic reactions. 6) Patients who have previously been on any murine or humanized MAb therapy.

发起方

Center of Molecular Inmunology (CIM)