Ministry of health integrated oncological program n°5/2006: 18F-Fluorometilcholine (18FFCH) PET/CT sensibility in diagnosis of breast cancer metastasis - N5/2006 - 01B

AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI0 个研究点目标入组 50 人开始时间: 2011年12月14日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•-female gender subjects only -previous primary breast cancer, radically treated to complete clinical remission, to clinician’s judgement -availability of clinical and pathologic documentation of primary disease, to be considered satisfactory to investigator’s judment (generally comprising histological diagnosis, assessment of ER, PgR, Erb-B2 status, pathologicl staging at diagnosis, plasma levels of CEA and 15.3, etc) -subjects must have been enrolled in routinary clinical follow-up schedule in oncologic centres -chemotherapy and/or radiotherapy ceased for at least 6 months -hormonal therapy allowed, to be suspended for 10 days after enrollment, till PET/CT examination -estabilished recent diagnosis of previously unrecognized metastatic disease diagnosis of metastatic disease should be estabilished on the basis of radiological evidence; full documentation of restaging need to be avalaible. Histological confirmation is preferred, but is not obligatory. Biopsy should be not more recent than 30 days. Some kinds of radiological examinations are to be considered obligatory (bone scan, whole body CT, MRI utilized for osseous lesions referred as suspect in bone scans for vertebrae, skull, pelvic bones, long bones).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•-pregnancy -chemotherapy or radiotherapy administration in previous 6 months -presence of different oncologic disease, including leukemia, lymphoma, plasma cell disease -presence of chronic liver disease, including chronic hepatitis ans cirrhosis -Karnofsky performance status <80% -actual or previous enrollment in different clinical trials with administration of ionizing radiation -ionizing radiation exposure due to work or profession -recent surgery or biopsies (<30 days) -inability to understand or subscribe an informed consent to participate to clinical trials, including being minor.

发起方

AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI