0 Ratings
ID

44577

Description

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI; ODM derived from: https://clinicaltrials.gov/show/NCT01067976

Link

https://clinicaltrials.gov/show/NCT01067976

Keywords

Versions (2)
  1. 8/26/19 8/26/19 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT01067976

    English

    Eligibility Breast Cancer NCT01067976

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    recent histologically proven diagnosis of breast cancer after having obtained x-ray mammography (xrm) of both breasts (according to american college of radiology [acr] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced magnetic resonance mammography (mrm) prior to surgery of the breast.
    Description

    Breast Carcinoma | Both breasts Mammography | Referral for Magnetic Resonance Mammography | Status pre- Operation on breast

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0678222
    UMLS CUI [2,1]
    C0222605
    UMLS CUI [2,2]
    C0024671
    UMLS CUI [3,1]
    C2585524
    UMLS CUI [3,2]
    C0024485
    UMLS CUI [3,3]
    C0024671
    UMLS CUI [4,1]
    C0332152
    UMLS CUI [4,2]
    C3714726
    if female, a digital xrm is required if any of the following criteria is met:
    Description

    Gender Requirement Digital Mammography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0860950
    1. patient is younger than 50 years;
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. patient has heterogeneously or extremely dense breasts;
    Description

    Breast Density Heterogeneous | Extremely Dense Breast

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1659543
    UMLS CUI [1,2]
    C0019409
    UMLS CUI [2]
    C1268647
    3. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
    Description

    Postmenopausal state Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232970
    UMLS CUI [1,2]
    C0332197
    if female of childbearing potential, mrm should be performed on the 7-14th day of the menstrual cycle.
    Description

    Childbearing Potential Magnetic Resonance Mammography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [1,3]
    C0024671
    has an estimated glomerular filtration rate (egfr) value >/= 60 ml/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
    Description

    Estimated Glomerular Filtration Rate | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3811844
    UMLS CUI [2]
    C0201976
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    is a female patient who is pregnant or lactating
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    has any contraindication to the mrm examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
    Description

    Medical contraindication Magnetic Resonance Mammography | Metallic implant | Phobia | Medical contraindication Gadolinium-based Contrast Agent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [1,3]
    C0024671
    UMLS CUI [2]
    C3693688
    UMLS CUI [3]
    C0349231
    UMLS CUI [4,1]
    C1301624
    UMLS CUI [4,2]
    C3249258
    has received any contrast agent within 24 hours prior to the study mrm, or is scheduled to receive any contrast agent within 24 hours after the study mrm.
    Description

    Contrast Media | Contrast Media Scheduled

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009924
    UMLS CUI [2,1]
    C0009924
    UMLS CUI [2,2]
    C0205539
    has severe cardiovascular disease (e.g., known long qt syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure new york heart association class iv) or acute stroke (< 48 hours)).
    Description

    Cardiovascular Disease Severe | Long QT Syndrome | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cerebrovascular accident

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C0023976
    UMLS CUI [3]
    C0027051
    UMLS CUI [4]
    C0002965
    UMLS CUI [5,1]
    C0018802
    UMLS CUI [5,2]
    C1275491
    UMLS CUI [6]
    C0038454
    has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 ml/min/1.73m^2).
    Description

    Renal Insufficiency Due to Hepatorenal Syndrome | Renal Insufficiency During Transplantation of liver Period | Renal Insufficiency Moderate | Renal Insufficiency Severe | Chronic Kidney Insufficiency Moderate | Chronic Kidney Insufficiency Severe | Glomerular Filtration Rate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1565489
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0019212
    UMLS CUI [2,1]
    C1565489
    UMLS CUI [2,2]
    C0347984
    UMLS CUI [2,3]
    C0023911
    UMLS CUI [2,4]
    C1948053
    UMLS CUI [3,1]
    C1565489
    UMLS CUI [3,2]
    C0205081
    UMLS CUI [4,1]
    C1565489
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [5,1]
    C0403447
    UMLS CUI [5,2]
    C0205081
    UMLS CUI [6,1]
    C0403447
    UMLS CUI [6,2]
    C0205082
    UMLS CUI [7]
    C0017654
    has received chemotherapy or hormonal therapy for breast cancer within 6 months.
    Description

    Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0678222
    UMLS CUI [2,1]
    C0279025
    UMLS CUI [2,2]
    C0678222
    has received hormone replacement therapy within 4 weeks prior to study drug administration.
    Description

    Hormone replacement therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0282402
    is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
    Description

    Operative Surgical Procedure Scheduled | Operative Surgical Procedure Required | Biopsy Scheduled | Biopsy Required

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0205539
    UMLS CUI [2,1]
    C0543467
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [3,1]
    C0005558
    UMLS CUI [3,2]
    C0205539
    UMLS CUI [4,1]
    C0005558
    UMLS CUI [4,2]
    C1514873
    has prior excisional biopsy or breast surgery less than 6 months before enrollment and between xrm and study mrm
    Description

    Excision biopsy Recently | Operation on breast Recently

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0184921
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C3714726
    UMLS CUI [2,2]
    C0332185
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    Similar models

    Eligibility Breast Cancer NCT01067976

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Breast Carcinoma | Both breasts Mammography | Referral for Magnetic Resonance Mammography | Status pre- Operation on breast
    Item
    recent histologically proven diagnosis of breast cancer after having obtained x-ray mammography (xrm) of both breasts (according to american college of radiology [acr] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced magnetic resonance mammography (mrm) prior to surgery of the breast.
    boolean
    C0678222 (UMLS CUI [1])
    C0222605 (UMLS CUI [2,1])
    C0024671 (UMLS CUI [2,2])
    C2585524 (UMLS CUI [3,1])
    C0024485 (UMLS CUI [3,2])
    C0024671 (UMLS CUI [3,3])
    C0332152 (UMLS CUI [4,1])
    C3714726 (UMLS CUI [4,2])
    Gender Requirement Digital Mammography
    Item
    if female, a digital xrm is required if any of the following criteria is met:
    boolean
    C0079399 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0860950 (UMLS CUI [1,3])
    Age
    Item
    1. patient is younger than 50 years;
    boolean
    C0001779 (UMLS CUI [1])
    Breast Density Heterogeneous | Extremely Dense Breast
    Item
    2. patient has heterogeneously or extremely dense breasts;
    boolean
    C1659543 (UMLS CUI [1,1])
    C0019409 (UMLS CUI [1,2])
    C1268647 (UMLS CUI [2])
    Postmenopausal state Absent
    Item
    3. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
    boolean
    C0232970 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Childbearing Potential Magnetic Resonance Mammography
    Item
    if female of childbearing potential, mrm should be performed on the 7-14th day of the menstrual cycle.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0024671 (UMLS CUI [1,3])
    Estimated Glomerular Filtration Rate | Creatinine measurement, serum
    Item
    has an estimated glomerular filtration rate (egfr) value >/= 60 ml/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
    boolean
    C3811844 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding
    Item
    is a female patient who is pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Medical contraindication Magnetic Resonance Mammography | Metallic implant | Phobia | Medical contraindication Gadolinium-based Contrast Agent
    Item
    has any contraindication to the mrm examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
    boolean
    C1301624 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0024671 (UMLS CUI [1,3])
    C3693688 (UMLS CUI [2])
    C0349231 (UMLS CUI [3])
    C1301624 (UMLS CUI [4,1])
    C3249258 (UMLS CUI [4,2])
    Contrast Media | Contrast Media Scheduled
    Item
    has received any contrast agent within 24 hours prior to the study mrm, or is scheduled to receive any contrast agent within 24 hours after the study mrm.
    boolean
    C0009924 (UMLS CUI [1])
    C0009924 (UMLS CUI [2,1])
    C0205539 (UMLS CUI [2,2])
    Cardiovascular Disease Severe | Long QT Syndrome | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cerebrovascular accident
    Item
    has severe cardiovascular disease (e.g., known long qt syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure new york heart association class iv) or acute stroke (< 48 hours)).
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0023976 (UMLS CUI [2])
    C0027051 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0018802 (UMLS CUI [5,1])
    C1275491 (UMLS CUI [5,2])
    C0038454 (UMLS CUI [6])
    Renal Insufficiency Due to Hepatorenal Syndrome | Renal Insufficiency During Transplantation of liver Period | Renal Insufficiency Moderate | Renal Insufficiency Severe | Chronic Kidney Insufficiency Moderate | Chronic Kidney Insufficiency Severe | Glomerular Filtration Rate
    Item
    has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 ml/min/1.73m^2).
    boolean
    C1565489 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0019212 (UMLS CUI [1,3])
    C1565489 (UMLS CUI [2,1])
    C0347984 (UMLS CUI [2,2])
    C0023911 (UMLS CUI [2,3])
    C1948053 (UMLS CUI [2,4])
    C1565489 (UMLS CUI [3,1])
    C0205081 (UMLS CUI [3,2])
    C1565489 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0403447 (UMLS CUI [5,1])
    C0205081 (UMLS CUI [5,2])
    C0403447 (UMLS CUI [6,1])
    C0205082 (UMLS CUI [6,2])
    C0017654 (UMLS CUI [7])
    Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma
    Item
    has received chemotherapy or hormonal therapy for breast cancer within 6 months.
    boolean
    C0392920 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])
    C0279025 (UMLS CUI [2,1])
    C0678222 (UMLS CUI [2,2])
    Hormone replacement therapy
    Item
    has received hormone replacement therapy within 4 weeks prior to study drug administration.
    boolean
    C0282402 (UMLS CUI [1])
    Operative Surgical Procedure Scheduled | Operative Surgical Procedure Required | Biopsy Scheduled | Biopsy Required
    Item
    is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
    boolean
    C0543467 (UMLS CUI [1,1])
    C0205539 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0005558 (UMLS CUI [3,1])
    C0205539 (UMLS CUI [3,2])
    C0005558 (UMLS CUI [4,1])
    C1514873 (UMLS CUI [4,2])
    Excision biopsy Recently | Operation on breast Recently
    Item
    has prior excisional biopsy or breast surgery less than 6 months before enrollment and between xrm and study mrm
    boolean
    C0184921 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C3714726 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
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