ID

27259

Beschrijving

111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01445054

Link

https://clinicaltrials.gov/show/NCT01445054

Trefwoorden

Versies (1)
  1. 06-11-17 06-11-17 -
Houder van rechten

See clinicaltrials.gov

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6 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01445054

Engels

Eligibility Breast Cancer NCT01445054

1 Formulieren  
Criteria
Beschrijving

Criteria

participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
Beschrijving

Primary malignant neoplasm | Neoplasm Metastasis | Exception Melanoma | Exception Basal cell carcinoma | Exception Sarcoma | Exception Lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C1306459
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025202
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1261473
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0024299
primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, ct or mri.
Beschrijving

Primary malignant neoplasm Diameter | Focus metastatic Diameter | Palpation | Ultrasonography | Mammography | CT | MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1306459
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0205234
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1301886
UMLS CUI [3]
C0030247
UMLS CUI [4]
C0041618
UMLS CUI [5]
C0024671
UMLS CUI [6]
C0040405
UMLS CUI [7]
C0024485
participant must be 18 years or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing ihc or fish analysis for her2/neu (erb2)
Beschrijving

Primary malignant neoplasm Tumor tissue Available | Neoplasm Lesion Tumor tissue Available | HER2/Neu Status Immunohistochemistry | HER2/Neu Status FISH

Datatype

boolean

Alias
UMLS CUI [1,1]
C1306459
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0475358
UMLS CUI [2,4]
C0470187
UMLS CUI [3,1]
C1512413
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C1512413
UMLS CUI [4,2]
C0162789
chemistry and cbc parameters: serum creatinine less than or equal to 1.4mg/dl. sgot and sgpt less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with gilbert s syndrome; platelet count must be greater than 100,00.
Beschrijving

Chemistry | Complete Blood Count | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Gilbert Disease | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0151339
UMLS CUI [2]
C0009555
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0017551
UMLS CUI [8]
C0032181
ecog performance score of 0 or 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
ability to provide informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
negative serum pregnancy test (within 48 hours of imaging agent injection) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of (111)indium trastuzumab if participant is of child bearing age.
Beschrijving

Childbearing Potential Serum pregnancy test negative | Imaging Agent Injection | Childbearing Potential Contraceptive methods | Contraception, Barrier | Sexual Abstinence | Exception Hormonal contraception | Indium 111 Trastuzumab Injection

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C1512628
UMLS CUI [2,2]
C1533685
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C2985296
UMLS CUI [7,1]
C1881194
UMLS CUI [7,2]
C1533685
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy to trastuzumab.
Beschrijving

Hypersensitivity trastuzumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
pregnant or lactating women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
Beschrijving

Enrollment | Delay Standard therapy Scheduled

Datatype

boolean

Alias
UMLS CUI [1]
C1516879
UMLS CUI [2,1]
C0205421
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C0205539
participants with an active second malignancy (excluding treated basal cell skin carcinoma).
Beschrijving

Second Cancer | Exception Basal cell carcinoma Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
history of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
Beschrijving

Heart Diseases | Myocardial Infarction | Cardiac Arrhythmia Treatment required for | Valvular disease Symptomatic | Cardiomyopathy | Pericarditis

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0332121
UMLS CUI [4,1]
C3258293
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0878544
UMLS CUI [6]
C0031046
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Beschrijving

Comorbidity Interferes with Clinical Trial Procedure | Comorbidity Interferes with Research results | Mental disorders Interfere with Clinical Trial Procedure | Mental disorders Interfere with Research results

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0184661
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0008976
UMLS CUI [3,4]
C0184661
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
participants with severe claustrophobia.
Beschrijving

Claustrophobia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
a participant who needs a nuclear medicine scan other than a pet scan as part of their work-up cannot enroll until these scans have been completed.
Beschrijving

Radionuclide Imaging Completed | Work up | Exception Positron-Emission Tomography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034606
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0750430
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0032743
gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 kg)
Beschrijving

Gamma Camera Scanning System Restriction | Body Weight Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0810610
UMLS CUI [1,2]
C0443288
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C0439801
with the exception of at13387 and pu-h71, and ad5f35her2ectm transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.
Beschrijving

Investigational New Drugs | Exception AT 13387 | Exception PU-H71 | Exception Autologous dendritic cell/adenovirus HER-2 vaccine

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2830135
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3502086
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1831756
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Similar models

Eligibility Breast Cancer NCT01445054

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Primary malignant neoplasm | Neoplasm Metastasis | Exception Melanoma | Exception Basal cell carcinoma | Exception Sarcoma | Exception Lymphoma
Item
participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
boolean
C1306459 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0025202 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1261473 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0024299 (UMLS CUI [6,2])
Primary malignant neoplasm Diameter | Focus metastatic Diameter | Palpation | Ultrasonography | Mammography | CT | MRI
Item
primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, ct or mri.
boolean
C1306459 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0205234 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0030247 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0024671 (UMLS CUI [5])
C0040405 (UMLS CUI [6])
C0024485 (UMLS CUI [7])
Age
Item
participant must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Primary malignant neoplasm Tumor tissue Available | Neoplasm Lesion Tumor tissue Available | HER2/Neu Status Immunohistochemistry | HER2/Neu Status FISH
Item
availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing ihc or fish analysis for her2/neu (erb2)
boolean
C1306459 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0475358 (UMLS CUI [2,3])
C0470187 (UMLS CUI [2,4])
C1512413 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C1512413 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
Chemistry | Complete Blood Count | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Gilbert Disease | Platelet Count measurement
Item
chemistry and cbc parameters: serum creatinine less than or equal to 1.4mg/dl. sgot and sgpt less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with gilbert s syndrome; platelet count must be greater than 100,00.
boolean
C0151339 (UMLS CUI [1])
C0009555 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0017551 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
ECOG performance status
Item
ecog performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
ability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Imaging Agent Injection | Childbearing Potential Contraceptive methods | Contraception, Barrier | Sexual Abstinence | Exception Hormonal contraception | Indium 111 Trastuzumab Injection
Item
negative serum pregnancy test (within 48 hours of imaging agent injection) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of (111)indium trastuzumab if participant is of child bearing age.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C1512628 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C2985296 (UMLS CUI [6,2])
C1881194 (UMLS CUI [7,1])
C1533685 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity trastuzumab
Item
known allergy to trastuzumab.
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Enrollment | Delay Standard therapy Scheduled
Item
participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
boolean
C1516879 (UMLS CUI [1])
C0205421 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Second Cancer | Exception Basal cell carcinoma Treated
Item
participants with an active second malignancy (excluding treated basal cell skin carcinoma).
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Heart Diseases | Myocardial Infarction | Cardiac Arrhythmia Treatment required for | Valvular disease Symptomatic | Cardiomyopathy | Pericarditis
Item
history of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C3258293 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0031046 (UMLS CUI [6])
Comorbidity Interferes with Clinical Trial Procedure | Comorbidity Interferes with Research results | Mental disorders Interfere with Clinical Trial Procedure | Mental disorders Interfere with Research results
Item
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0184661 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Claustrophobia Severe
Item
participants with severe claustrophobia.
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Radionuclide Imaging Completed | Work up | Exception Positron-Emission Tomography
Item
a participant who needs a nuclear medicine scan other than a pet scan as part of their work-up cannot enroll until these scans have been completed.
boolean
C0034606 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0750430 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
Gamma Camera Scanning System Restriction | Body Weight Limited
Item
gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 kg)
boolean
C0810610 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Investigational New Drugs | Exception AT 13387 | Exception PU-H71 | Exception Autologous dendritic cell/adenovirus HER-2 vaccine
Item
with the exception of at13387 and pu-h71, and ad5f35her2ectm transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.
boolean
C0013230 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2830135 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3502086 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1831756 (UMLS CUI [4,2])
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