Immuno gamma scanning using 14F7 MAbB marked with Tc99 in patients with metastatic breast tumor, phase II.

Center of Molecular Immunology (CIM)0 个研究点目标入组 15 人开始时间: 2010年12月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

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 (to participate in the clinical trial) in writing. 2)Patients with breast carcinoma phase IV upon diagnosis or evolving metastatic disease, with cyto-histological confirmation of base disease and metastasis by imaging or cyto-histological test. 3)Patients aged between 18 and 80 both inclusive. 4)Patients with general condition lower than or equal to 2, according to WHO criteria. 5)Preserved kidney function with normal creatinine values ranking from 35 to 132mmol/l. 6)Patients with hemoglobin values over 10g/l, leucocytes over 4,000 /mm3, platelets 100 x 109, transaminase and alkaline phosphatase up to 2.5 times over normal reference values.

•1)Pregnancy or breastfeeding. 2)Reproductive-age patients not using contraceptives. 3)Feverish condition due to acute or serious infectious diseases or convalescence (not exceeding 37.5 oC). 4)Patients who have suffered from decompensated chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis or high blood pressure. 5)Patients with acute allergic conditions or severe allergic reaction history. 6)Patients who have previously been on some murine or humanized MAb.

发起方

Center of Molecular Immunology (CIM)