ID

15606

Description

Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver; ODM derived from: https://clinicaltrials.gov/show/NCT00041808

Link

https://clinicaltrials.gov/show/NCT00041808

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastases, Neoplasm NCT00041808

English

Eligibility Metastases, Neoplasm NCT00041808

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a karnofsky (or equivalent) performance status > 60 and an expected survival of > 2 months
Description

karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patients agreeing to use a medically effective method of contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients able to understand and give written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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
Description

center of the tumor mass

Data type

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C0205099
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or lactating
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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
Description

metastatic liver cancer

Data type

boolean

Alias
UMLS CUI [1]
C0494165
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
Description

laboratory abnormalities

Data type

boolean

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

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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
Description

cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
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
Description

second invasive cancer

Data type

boolean

Alias
UMLS CUI [1]
C0677898
patients with documented evidence of hemachromatosis or hemosiderosis
Description

hemachromatosis or hemosiderosis

Data type

boolean

Alias
UMLS CUI [1]
C0018995
UMLS CUI [2]
C0019114
patients with ct or ultrasound evidence of portal vein invasion or thrombosis
Description

portal vein invasion or thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0585133
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.
Description

anthracycline therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0428772
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Similar models

Eligibility Metastases, Neoplasm NCT00041808

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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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