Eligibility Metastases, Neoplasm NCT00041808

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StudyEvent: Eligibility
1. Eligibility Metastases, Neoplasm NCT00041808

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

karnofsky

Item

patients with a karnofsky (or equivalent) performance status > 60 and an expected survival of > 2 months

boolean

C0206065 (UMLS CUI [1])

contraception

Item

patients agreeing to use a medically effective method of contraception

boolean

C0700589 (UMLS CUI [1])

informed consent

Item

patients able to understand and give written informed consent

boolean

C0021430 (UMLS CUI [1])

center of the tumor mass

Item

the center of the tumor mass must be < or = 14 cm from the anterior or lateral abdominal wall as determined by cross sectional imaging measured at baseline. this is required for optimal retention of mtc-dox by the magnetic field. if more than one tumor mass is present, all of the treated tumor masses must meet this criterion

boolean

C3273930 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

pregnant or lactating

Item

women who are pregnant or lactating

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

metastatic liver cancer

Item

patient’s with metastatic liver cancer, or other primary liver cancer excluding hcc, with diffuse disease that does not have focal area(s) conducive to local regional therapy

boolean

C0494165 (UMLS CUI [1])

laboratory abnormalities

Item

patients with the following laboratory abnormalities:hemoglobin < 10.0 g/dl;granulocyte count < 1,500 per mm3;platelet count < 50,000 per mm3; lymphocyte count < 0.5 x 10 to the 9th per l; total bilirubin >/= 3.0 mg/dl;ast or alt >/= 5x the upper limit of normal;inr >/= 1.3; creatinine >/= 2.0 mg/dl

boolean

C0518015 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0201913 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0525032 (UMLS CUI [8])
C0010294 (UMLS CUI [9])

comorbidity

Item

patients with either significant cardiovascular disease or any other organ system dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the test material. patients with evidence of a myocardial infarction within six (6) months prior to this trial will be excluded.

boolean

C0009488 (UMLS CUI [1])

cardiac pacemaker

Item

patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet

boolean

C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])

second invasive cancer

Item

patients at the time of study entry with a second invasive cancer other than basal cell and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

boolean

C0677898 (UMLS CUI [1])

hemachromatosis or hemosiderosis

Item

patients with documented evidence of hemachromatosis or hemosiderosis

boolean

C0018995 (UMLS CUI [1])
C0019114 (UMLS CUI [2])

portal vein invasion or thrombosis

Item

patients with ct or ultrasound evidence of portal vein invasion or thrombosis

boolean

C0585133 (UMLS CUI [1])

anthracycline therapy

Item

patients who have had prior anthracycline therapy with a left ventricular ejection fraction (lvef) <50%, as measured by either multigated radionuclide angiography (muga) scan or echocardiogram.

boolean

C0282564 (UMLS CUI [1])
C0428772 (UMLS CUI [2])

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Eligibility Metastases, Neoplasm NCT00041808