ID

39343

Beschreibung

Imaging Study for FdCyd and THU Cancer Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01479348

Link

https://clinicaltrials.gov/show/NCT01479348

Stichworte

Versionen (1)
  1. 23.12.19 23.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. Dezember 2019

DOI

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Creative Commons BY 4.0
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    Eligibility Head and Neck Neoplasms NCT01479348

    Englisch

    Eligibility Head and Neck Neoplasms NCT01479348

    1 Formulare  
    Criteria
    Beschreibung

    Criteria

    enrolled in the nih phase ii clinical protocol evaluating fdcyd with thu (09-c-0214) with target lesion measured as greater than or equal to 10mm with spiral ct scan.
    Beschreibung

    Study Subject Participation Status Clinical Trial Specified | FdCyd | THU | Target Lesion Size Spiral CT

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0205369
    UMLS CUI [2]
    C0049174
    UMLS CUI [3]
    C0039677
    UMLS CUI [4,1]
    C2986546
    UMLS CUI [4,2]
    C0456389
    UMLS CUI [4,3]
    C0860888
    written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    for females: negative serum pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
    Beschreibung

    Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0430061
    UMLS CUI [2]
    C0232970
    UMLS CUI [3]
    C0020699
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participants with severe claustrophobia unresponsive to oral anxiolytics
    Beschreibung

    Claustrophobia Severe | Unresponsive to Anti-Anxiety Agents Oral

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008909
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0205269
    UMLS CUI [2,2]
    C0040616
    UMLS CUI [2,3]
    C1527415
    subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry
    Beschreibung

    Body Weight | Body Weight Inappropriate Scanner | Study Subject Inappropriate Imaging Technique

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005910
    UMLS CUI [2,1]
    C0005910
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [2,3]
    C1710020
    UMLS CUI [3,1]
    C0681850
    UMLS CUI [3,2]
    C1548788
    UMLS CUI [3,3]
    C0079595
    known allergy to fdcyd
    Beschreibung

    Hypersensitivity FdCyd

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0049174
    the subject is unable to lie still for 75 minutes
    Beschreibung

    Lacking Able to lie down Quiet Duration

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332268
    UMLS CUI [1,2]
    C0560841
    UMLS CUI [1,3]
    C0439654
    UMLS CUI [1,4]
    C0449238
    5 pregnant or lactating women. pregnant women are excluded from this study because the effects of 18f-fdcyd in pregnancy are not known. because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18ffdcyd in the mother, breastfeeding should be discontinued if the mother receives 18ffdcyd
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
    Beschreibung

    Medical condition Interferes with Interventional procedure | Mental condition Interferes with Interventional procedure | Medical condition Interferes with Research results | Mental condition Interferes with Research results

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0184661
    UMLS CUI [2,1]
    C3840291
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C0184661
    UMLS CUI [3,1]
    C3843040
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C0683954
    UMLS CUI [4,1]
    C3840291
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C0683954
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Head and Neck Neoplasms NCT01479348

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Study Subject Participation Status Clinical Trial Specified | FdCyd | THU | Target Lesion Size Spiral CT
    Item
    enrolled in the nih phase ii clinical protocol evaluating fdcyd with thu (09-c-0214) with target lesion measured as greater than or equal to 10mm with spiral ct scan.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0205369 (UMLS CUI [1,3])
    C0049174 (UMLS CUI [2])
    C0039677 (UMLS CUI [3])
    C2986546 (UMLS CUI [4,1])
    C0456389 (UMLS CUI [4,2])
    C0860888 (UMLS CUI [4,3])
    Informed Consent
    Item
    written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
    boolean
    C0021430 (UMLS CUI [1])
    Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy
    Item
    for females: negative serum pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
    boolean
    C0079399 (UMLS CUI [1,1])
    C0430061 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    C0020699 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Claustrophobia Severe | Unresponsive to Anti-Anxiety Agents Oral
    Item
    participants with severe claustrophobia unresponsive to oral anxiolytics
    boolean
    C0008909 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205269 (UMLS CUI [2,1])
    C0040616 (UMLS CUI [2,2])
    C1527415 (UMLS CUI [2,3])
    Body Weight | Body Weight Inappropriate Scanner | Study Subject Inappropriate Imaging Technique
    Item
    subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry
    boolean
    C0005910 (UMLS CUI [1])
    C0005910 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C1710020 (UMLS CUI [2,3])
    C0681850 (UMLS CUI [3,1])
    C1548788 (UMLS CUI [3,2])
    C0079595 (UMLS CUI [3,3])
    Hypersensitivity FdCyd
    Item
    known allergy to fdcyd
    boolean
    C0020517 (UMLS CUI [1,1])
    C0049174 (UMLS CUI [1,2])
    Lacking Able to lie down Quiet Duration
    Item
    the subject is unable to lie still for 75 minutes
    boolean
    C0332268 (UMLS CUI [1,1])
    C0560841 (UMLS CUI [1,2])
    C0439654 (UMLS CUI [1,3])
    C0449238 (UMLS CUI [1,4])
    Pregnancy | Breast Feeding
    Item
    5 pregnant or lactating women. pregnant women are excluded from this study because the effects of 18f-fdcyd in pregnancy are not known. because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18ffdcyd in the mother, breastfeeding should be discontinued if the mother receives 18ffdcyd
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Medical condition Interferes with Interventional procedure | Mental condition Interferes with Interventional procedure | Medical condition Interferes with Research results | Mental condition Interferes with Research results
    Item
    participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
    boolean
    C3843040 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    C3840291 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C0184661 (UMLS CUI [2,3])
    C3843040 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C0683954 (UMLS CUI [3,3])
    C3840291 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C0683954 (UMLS CUI [4,3])
    Zum Seitenanfang zurückkehren 

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