ID

19614

Description

Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants; ODM derived from: https://clinicaltrials.gov/show/NCT00474604

Link

https://clinicaltrials.gov/show/NCT00474604

Keywords

Versions (1)
  1. 1/16/17 1/16/17 -
Uploaded on

January 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00474604

English

Eligibility Breast Cancer NCT00474604

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women who satisfy the following conditions are the only subjects who will be eligible for this study:
Description

Gender criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
normal volunteers
Description

Normal Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C3661466
subjects with known or suspected breast disease
Description

Breast Disease | Breast Disease Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0006145
UMLS CUI [2,1]
C0006145
UMLS CUI [2,2]
C0750491
subjects must have signed an approved consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects must be ≥ 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the protocol nurse will check with the patient that there is no h/o kidney disease
Description

Kidney Disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0332197
normal creatinine and estimated gfr* within 30 days under the following circumstances
Description

Creatinine normal | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0860945
UMLS CUI [2]
C3811844
had abnormal creatinine in the last 60 days
Description

Serum creatinine abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438243
are over 60 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has received chemotherapy within the past 30 days
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
has diabetes, hiv, renal disease or hx of renal cancer
Description

Diabetes Mellitus | HIV Infection | Kidney Disease | Renal carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0022658
UMLS CUI [4]
C1378703
* gfr will be calculated using: http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
patients with an egfr>90ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent.
Description

Estimated Glomerular Filtration Rate | Chemotherapy deteriorating Renal function | Therapeutic procedure deteriorating Renal function | Condition deteriorating Renal function | Gadolinium Agent

Data type

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1457868
UMLS CUI [2,3]
C0232804
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1457868
UMLS CUI [3,3]
C0232804
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1457868
UMLS CUI [4,3]
C0232804
UMLS CUI [5,1]
C0016911
UMLS CUI [5,2]
C1254351
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
children will be excluded from this study.
Description

Children

Data type

boolean

Alias
UMLS CUI [1]
C0008059
pregnant women and women who are breast feeding will be excluded from this study. (the vanderbilt university medical center radiology "mri procedure screening form" will be used to identify and exclude subjects who are pregnant or breastfeeding. a urine pregnancy test/or serum beta hcg will also be performed for each pre-menopausal subject.)
Description

Pregnancy | Breast Feeding | Premenopausal state Urine pregnancy test | Premenopausal state Serum Beta-HCG Test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0430056
UMLS CUI [4,1]
C0232969
UMLS CUI [4,2]
C1255526
subjects found to have any constitutionally present non-mr compatible ferromagnetic materials will be excluded from this study.
Description

Materials Inappropriate Magnetic Resonance

Data type

boolean

Alias
UMLS CUI [1,1]
C0520510
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0917874
patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
Description

Illness Ineligibility Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0008976
subjects for whom an mri is technically not feasible (e.g. breast volume, obesity)
Description

Magnetic Resonance Imaging | Patient unsuitable for procedure Due to Breast Volume | Patient unsuitable for procedure Due to Obesity

Data type

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2,1]
C3839996
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0006141
UMLS CUI [2,4]
C0449468
UMLS CUI [3,1]
C3839996
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0028754
subjects who have vascular access ports or other implanted devices rated as anything other than "safe" or "conditional 6"
Description

Vascular Access Ports Safety of devices Problem | Implants Safety of devices Problem

Data type

boolean

Alias
UMLS CUI [1,1]
C1608324
UMLS CUI [1,2]
C0086139
UMLS CUI [1,3]
C0033213
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0086139
UMLS CUI [2,3]
C0033213
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Similar models

Eligibility Breast Cancer NCT00474604

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender criteria Fulfill
Item
women who satisfy the following conditions are the only subjects who will be eligible for this study:
boolean
C0079399 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Normal Volunteers
Item
normal volunteers
boolean
C3661466 (UMLS CUI [1])
Breast Disease | Breast Disease Suspected
Item
subjects with known or suspected breast disease
boolean
C0006145 (UMLS CUI [1])
C0006145 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Informed Consent
Item
subjects must have signed an approved consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
subjects must be ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Kidney Disease Absent
Item
the protocol nurse will check with the patient that there is no h/o kidney disease
boolean
C0022658 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Creatinine normal | Estimated Glomerular Filtration Rate
Item
normal creatinine and estimated gfr* within 30 days under the following circumstances
boolean
C0860945 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Serum creatinine abnormal
Item
had abnormal creatinine in the last 60 days
boolean
C0438243 (UMLS CUI [1])
Age
Item
are over 60 years of age
boolean
C0001779 (UMLS CUI [1])
Chemotherapy
Item
has received chemotherapy within the past 30 days
boolean
C0392920 (UMLS CUI [1])
Diabetes Mellitus | HIV Infection | Kidney Disease | Renal carcinoma
Item
has diabetes, hiv, renal disease or hx of renal cancer
boolean
C0011849 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1378703 (UMLS CUI [4])
Estimated Glomerular Filtration Rate
Item
* gfr will be calculated using: http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
boolean
C3811844 (UMLS CUI [1])
Estimated Glomerular Filtration Rate | Chemotherapy deteriorating Renal function | Therapeutic procedure deteriorating Renal function | Condition deteriorating Renal function | Gadolinium Agent
Item
patients with an egfr>90ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent.
boolean
C3811844 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1457868 (UMLS CUI [2,2])
C0232804 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1457868 (UMLS CUI [3,2])
C0232804 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1457868 (UMLS CUI [4,2])
C0232804 (UMLS CUI [4,3])
C0016911 (UMLS CUI [5,1])
C1254351 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Children
Item
children will be excluded from this study.
boolean
C0008059 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Urine pregnancy test | Premenopausal state Serum Beta-HCG Test
Item
pregnant women and women who are breast feeding will be excluded from this study. (the vanderbilt university medical center radiology "mri procedure screening form" will be used to identify and exclude subjects who are pregnant or breastfeeding. a urine pregnancy test/or serum beta hcg will also be performed for each pre-menopausal subject.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
C0232969 (UMLS CUI [4,1])
C1255526 (UMLS CUI [4,2])
Materials Inappropriate Magnetic Resonance
Item
subjects found to have any constitutionally present non-mr compatible ferromagnetic materials will be excluded from this study.
boolean
C0520510 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0917874 (UMLS CUI [1,3])
Illness Ineligibility Clinical Trial
Item
patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
boolean
C0221423 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Magnetic Resonance Imaging | Patient unsuitable for procedure Due to Breast Volume | Patient unsuitable for procedure Due to Obesity
Item
subjects for whom an mri is technically not feasible (e.g. breast volume, obesity)
boolean
C0024485 (UMLS CUI [1])
C3839996 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
C0449468 (UMLS CUI [2,4])
C3839996 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0028754 (UMLS CUI [3,3])
Vascular Access Ports Safety of devices Problem | Implants Safety of devices Problem
Item
subjects who have vascular access ports or other implanted devices rated as anything other than "safe" or "conditional 6"
boolean
C1608324 (UMLS CUI [1,1])
C0086139 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,3])
C0021102 (UMLS CUI [2,1])
C0086139 (UMLS CUI [2,2])
C0033213 (UMLS CUI [2,3])
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