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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