ID

27397

Beschreibung

Computed Tomography (CT) Perfusion Imaging of Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00905801

Link

https://clinicaltrials.gov/show/NCT00905801

Stichworte

Versionen (1)
  1. 13.11.17 13.11.17 -
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See clinicaltrials.gov

Hochgeladen am

13. November 2017

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma, Non Small Cell Lung NCT00905801

Englisch

Eligibility Carcinoma, Non Small Cell Lung NCT00905801

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with any stage non-small cell lung cancer (nsclc) who will undergo imaging with ct of the chest with intravenous contrast as standard of care. other imaging tests will be performed as clinically indicated.
Beschreibung

Non-Small Cell Lung Carcinoma TNM clinical staging | CT with intravenous contrast Chest | Imaging other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0202653
UMLS CUI [2,2]
C0817096
UMLS CUI [3]
C0025086
patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed.
Beschreibung

Systemic therapy | Chemotherapy | Investigational New Drugs | Therapeutic radiology procedure | Adjuvant therapy Absent | Therapeutic procedure Postoperative Absent | Neoadjuvant Therapy allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0013230
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C0677850
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0032790
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C0600558
UMLS CUI [7,2]
C0683607
histologically or cytologically proven nsclc.
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
at least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to response evaluation criteria in solid tumors (recist); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. a scan within 3-6 months prior to registration can be used as the baseline scan.
Beschreibung

Measurable Disease Primary Size Quantity | Lesion thorax | Lesion supraclavicular | Lesion Malignant Biopsy | Lesion Malignant Imaging study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C1406924
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0446461
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0205282
UMLS CUI [4,3]
C0005558
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0205282
UMLS CUI [5,3]
C1881134
age 18 years or older and ability to provide informed consent.
Beschreibung

Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding
Beschreibung

Sexually active Contraceptive methods | Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0006147
UMLS CUI [3,3]
C0332197
subjects must have normal renal function to participate. standard laboratory testing to evaluate renal function will be performed prior to administering iv contrast and will be available as standard of care. renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 bsa, derived from the patients' serum creatinine concentration.
Beschreibung

Renal function | Kidney Function Tests | Administration Intravenous contrast | Renal Insufficiency | Glomerular Filtration Rate Body Surface Area | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0022662
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C4072741
UMLS CUI [4]
C1565489
UMLS CUI [5,1]
C0017654
UMLS CUI [5,2]
C0005902
UMLS CUI [6]
C0201976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding;
Beschreibung

Reproductive potential Sexually active Contraceptive methods Unwilling | Reproductive potential Sexually active Contraceptive methods Unable | Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C1299582
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
established allergy to iodine containing contrast media
Beschreibung

Iodine contrast allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C4022917
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Ähnliche Modelle

Eligibility Carcinoma, Non Small Cell Lung NCT00905801

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | CT with intravenous contrast Chest | Imaging other
Item
patient with any stage non-small cell lung cancer (nsclc) who will undergo imaging with ct of the chest with intravenous contrast as standard of care. other imaging tests will be performed as clinically indicated.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0202653 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C0025086 (UMLS CUI [3])
Systemic therapy | Chemotherapy | Investigational New Drugs | Therapeutic radiology procedure | Adjuvant therapy Absent | Therapeutic procedure Postoperative Absent | Neoadjuvant Therapy allowed
Item
patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed.
boolean
C1515119 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0677850 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0032790 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C0600558 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically proven nsclc.
boolean
C0007131 (UMLS CUI [1])
Measurable Disease Primary Size Quantity | Lesion thorax | Lesion supraclavicular | Lesion Malignant Biopsy | Lesion Malignant Imaging study
Item
at least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to response evaluation criteria in solid tumors (recist); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. a scan within 3-6 months prior to registration can be used as the baseline scan.
boolean
C1513041 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1406924 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0446461 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0205282 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C0205282 (UMLS CUI [5,2])
C1881134 (UMLS CUI [5,3])
Age | Informed Consent
Item
age 18 years or older and ability to provide informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Sexually active Contraceptive methods | Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent
Item
subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Renal function | Kidney Function Tests | Administration Intravenous contrast | Renal Insufficiency | Glomerular Filtration Rate Body Surface Area | Creatinine measurement, serum
Item
subjects must have normal renal function to participate. standard laboratory testing to evaluate renal function will be performed prior to administering iv contrast and will be available as standard of care. renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 bsa, derived from the patients' serum creatinine concentration.
boolean
C0232804 (UMLS CUI [1])
C0022662 (UMLS CUI [2])
C1533734 (UMLS CUI [3,1])
C4072741 (UMLS CUI [3,2])
C1565489 (UMLS CUI [4])
C0017654 (UMLS CUI [5,1])
C0005902 (UMLS CUI [5,2])
C0201976 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Reproductive potential Sexually active Contraceptive methods Unwilling | Reproductive potential Sexually active Contraceptive methods Unable | Pregnancy | Breast Feeding
Item
subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding;
boolean
C4034483 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C4034483 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Iodine contrast allergy
Item
established allergy to iodine containing contrast media
boolean
C4022917 (UMLS CUI [1])
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