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ID

43679

Beskrivning

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02226276

Länk

https://clinicaltrials.gov/show/NCT02226276

Nyckelord

Versioner (2)
  1. 2016-04-26 2016-04-26 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Bone Metastases NCT02226276

    Engelsk

    Eligibility Bone Metastases NCT02226276

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    women with metastatic her2-positive breast cancers whose disease has progressed on first-line trastuzumab + chemotherapy will be considered eligible for study participation if they meet the following criteria:
    Beskrivning

    Woman Metastatic HER2-positive carcinoma of breast | First line treatment Trastuzumab | Chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0043210
    UMLS CUI [1,2]
    C1960398
    UMLS CUI [1,3]
    C0036525
    UMLS CUI [2,1]
    C1708063
    UMLS CUI [2,2]
    C0728747
    UMLS CUI [3]
    C0392920
    participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained within 28 days prior to enrollment; patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
    Beskrivning

    Woman Carcinoma breast stage IV | Biopsy | Metastatic Neoplasm Lung | Metastatic Neoplasm Liver | Metastatic Neoplasm soft tissue | Metastatic Neoplasm Skeletal bone

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0043210
    UMLS CUI [1,2]
    C0278488
    UMLS CUI [2]
    C0005558
    UMLS CUI [3,1]
    C2939420
    UMLS CUI [3,2]
    C0024109
    UMLS CUI [4,1]
    C2939420
    UMLS CUI [4,2]
    C0023884
    UMLS CUI [5,1]
    C2939420
    UMLS CUI [5,2]
    C0225317
    UMLS CUI [6,1]
    C2939420
    UMLS CUI [6,2]
    C0262950
    at least 1 site of metastasis >= 20 mm in mean diameter must be identified
    Beskrivning

    Neoplasm Metastasis Site Diameter

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C0205145
    UMLS CUI [1,3]
    C1301886
    the cancer must over express her2 as determined by immunohistochemistry (ihc) and/or fluorescence in situ hybridization (fish)
    Beskrivning

    Quantitative HER2 immunohistochemistry (IHC) evaluation of breast cancer | Fluorescent in Situ Hybridization

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3248285
    UMLS CUI [2]
    C0162789
    patients may not have received trastuzumab within 6 weeks of projected 64cu-dota-trastuzumab/pet-ct
    Beskrivning

    trastuzumab | 64Cu-DOTA-trastuzumab | PET/CT scan

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0728747
    UMLS CUI [2]
    C2745103
    UMLS CUI [3]
    C1699633
    participants must have normal cardiac ejection fraction
    Beskrivning

    Normal cardiac ejection fraction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3661818
    planned therapy with ado-trastuzumab emtansine
    Beskrivning

    Planned Therapeutic procedure ado-trastuzumab emtansine

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [1,3]
    C2935436
    ability to provide informed consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    patients that may need dose reduction to commence cycle 1 treatment
    Beskrivning

    Dosage Reduced | Therapeutic procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0392756
    UMLS CUI [2]
    C0087111
    eastern cooperative oncology group (ecog) performance status of 0-2
    Beskrivning

    ECOG Performance Status 0 | ECOG Performance Status 1 | ECOG Performance Status 2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3830346
    UMLS CUI [2]
    C3830345
    UMLS CUI [3]
    C3830344
    negative serum pregnancy test (female of childbearing potential only)
    Beskrivning

    Serum pregnancy test negative Female Childbearing Potential

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430061
    UMLS CUI [1,2]
    C0086287
    UMLS CUI [1,3]
    C3831118
    patients must have adequate cardiac function; left ventricular ejection fraction (lvef) >= 50% as determined by multi gated acquisition (muga) scan or echocardiogram
    Beskrivning

    Cardiac function | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232164
    UMLS CUI [2]
    C0428772
    UMLS CUI [3]
    C0521317
    UMLS CUI [4]
    C0013516
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participants who have received trastuzumab within the prior 36 days
    Beskrivning

    Received trastuzumab

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514756
    UMLS CUI [1,2]
    C0728747
    participants who are not considered candidates for ado-trastuzumab-emtansine
    Beskrivning

    Not Eligible | ado-trastuzumab emtansine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1555471
    UMLS CUI [2]
    C2935436
    no metastatic sites >= 20 mm
    Beskrivning

    site, metastatic cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0280457
    concurrent malignancy other than skin cancer
    Beskrivning

    Malignant Neoplasm Other | Malignant neoplasm of skin

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0007114
    inability to provide informed consent
    Beskrivning

    Unable Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582
    UMLS CUI [1,2]
    C0021430
    Tillbaka till toppen

    Similar models

    Eligibility Bone Metastases NCT02226276

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Woman Metastatic HER2-positive carcinoma of breast | First line treatment Trastuzumab | Chemotherapy
    Item
    women with metastatic her2-positive breast cancers whose disease has progressed on first-line trastuzumab + chemotherapy will be considered eligible for study participation if they meet the following criteria:
    boolean
    C0043210 (UMLS CUI [1,1])
    C1960398 (UMLS CUI [1,2])
    C0036525 (UMLS CUI [1,3])
    C1708063 (UMLS CUI [2,1])
    C0728747 (UMLS CUI [2,2])
    C0392920 (UMLS CUI [3])
    Woman Carcinoma breast stage IV | Biopsy | Metastatic Neoplasm Lung | Metastatic Neoplasm Liver | Metastatic Neoplasm soft tissue | Metastatic Neoplasm Skeletal bone
    Item
    participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained within 28 days prior to enrollment; patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
    boolean
    C0043210 (UMLS CUI [1,1])
    C0278488 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [2])
    C2939420 (UMLS CUI [3,1])
    C0024109 (UMLS CUI [3,2])
    C2939420 (UMLS CUI [4,1])
    C0023884 (UMLS CUI [4,2])
    C2939420 (UMLS CUI [5,1])
    C0225317 (UMLS CUI [5,2])
    C2939420 (UMLS CUI [6,1])
    C0262950 (UMLS CUI [6,2])
    Neoplasm Metastasis Site Diameter
    Item
    at least 1 site of metastasis >= 20 mm in mean diameter must be identified
    boolean
    C0027627 (UMLS CUI [1,1])
    C0205145 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [1,3])
    Quantitative HER2 immunohistochemistry (IHC) evaluation of breast cancer | Fluorescent in Situ Hybridization
    Item
    the cancer must over express her2 as determined by immunohistochemistry (ihc) and/or fluorescence in situ hybridization (fish)
    boolean
    C3248285 (UMLS CUI [1])
    C0162789 (UMLS CUI [2])
    trastuzumab | 64Cu-DOTA-trastuzumab | PET/CT scan
    Item
    patients may not have received trastuzumab within 6 weeks of projected 64cu-dota-trastuzumab/pet-ct
    boolean
    C0728747 (UMLS CUI [1])
    C2745103 (UMLS CUI [2])
    C1699633 (UMLS CUI [3])
    Normal cardiac ejection fraction
    Item
    participants must have normal cardiac ejection fraction
    boolean
    C3661818 (UMLS CUI [1])
    Planned Therapeutic procedure ado-trastuzumab emtansine
    Item
    planned therapy with ado-trastuzumab emtansine
    boolean
    C0087111 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C2935436 (UMLS CUI [1,3])
    Informed Consent
    Item
    ability to provide informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Dosage Reduced | Therapeutic procedure
    Item
    patients that may need dose reduction to commence cycle 1 treatment
    boolean
    C0178602 (UMLS CUI [1,1])
    C0392756 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2])
    ECOG Performance Status 0 | ECOG Performance Status 1 | ECOG Performance Status 2
    Item
    eastern cooperative oncology group (ecog) performance status of 0-2
    boolean
    C3830346 (UMLS CUI [1])
    C3830345 (UMLS CUI [2])
    C3830344 (UMLS CUI [3])
    Serum pregnancy test negative Female Childbearing Potential
    Item
    negative serum pregnancy test (female of childbearing potential only)
    boolean
    C0430061 (UMLS CUI [1,1])
    C0086287 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [1,3])
    Cardiac function | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
    Item
    patients must have adequate cardiac function; left ventricular ejection fraction (lvef) >= 50% as determined by multi gated acquisition (muga) scan or echocardiogram
    boolean
    C0232164 (UMLS CUI [1])
    C0428772 (UMLS CUI [2])
    C0521317 (UMLS CUI [3])
    C0013516 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    Received trastuzumab
    Item
    participants who have received trastuzumab within the prior 36 days
    boolean
    C1514756 (UMLS CUI [1,1])
    C0728747 (UMLS CUI [1,2])
    Not Eligible | ado-trastuzumab emtansine
    Item
    participants who are not considered candidates for ado-trastuzumab-emtansine
    boolean
    C1555471 (UMLS CUI [1])
    C2935436 (UMLS CUI [2])
    site, metastatic cancer
    Item
    no metastatic sites >= 20 mm
    boolean
    C0280457 (UMLS CUI [1])
    Malignant Neoplasm Other | Malignant neoplasm of skin
    Item
    concurrent malignancy other than skin cancer
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0007114 (UMLS CUI [2])
    Unable Informed Consent
    Item
    inability to provide informed consent
    boolean
    C1299582 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Tillbaka till toppen 

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