ID

31557

Description

USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00622973

Link

https://clinicaltrials.gov/show/NCT00622973

Keywords

Versions (1)
  1. 9/4/18 9/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00622973

English

Eligibility Prostate Cancer NCT00622973

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically proven prostate cancer (t1-2n0m0 gleason score 6-10) scheduled for radical prostatectomy or patients with histologically proven bladder cancer (t1-3bn0m0g3) scheduled for cystectomy
Description

Prostate carcinoma TNM clinical staging | Prostate carcinoma Gleason score | Radical prostatectomy Scheduled | Carcinoma of bladder TNM clinical staging | Cystectomy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C3203027
UMLS CUI [3,1]
C0194810
UMLS CUI [3,2]
C0205539
UMLS CUI [4,1]
C0699885
UMLS CUI [4,2]
C3258246
UMLS CUI [5,1]
C0010651
UMLS CUI [5,2]
C0205539
written informed consent to participate in this trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with contraindications for mri (e.g. pacemaker, metal implants, claustrophobia).
Description

Contraindication Magnetic Resonance Imaging | Artificial cardiac pacemaker | Metallic implant | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0008909
patients in a critical cardiovascular state, with risk of decompensation after administration of the uspio contrast agent.
Description

Status Cardiovascular Critical | At risk Heart Decompensation | Status post Administration USPIO

Data type

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C3887460
UMLS CUI [1,3]
C1511545
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C1961112
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0386370
patients with hemochromatosis or an allergy to dextran or iron compounds.
Description

Hemochromatosis | Dextran allergy | Compound iron preparations allergy

Data type

boolean

Alias
UMLS CUI [1]
C0018995
UMLS CUI [2]
C0571755
UMLS CUI [3]
C0571799
pregnant or breast-feeding women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have received gadolinium complexes within 2 days or iron oxide particles within 7 days before mri.
Description

Gadolinium Before MRI | Ferric oxide Particles Before MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0016911
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0060240
UMLS CUI [2,2]
C0597177
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C0024485
patients who underwent chemotherapy or radiotherapy before surgery.
Description

Chemotherapy Before Operative Surgical Procedures | Therapeutic radiology procedure Before Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0543467
patients whose degree of cooperation is incompatible with carrying out the study.
Description

Compliance behavior Inconsistent Study Execution

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0681872
patients with contraindications to glucagon administration.
Description

Medical contraindication Glucagon

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0017687
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Similar models

Eligibility Prostate Cancer NCT00622973

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma TNM clinical staging | Prostate carcinoma Gleason score | Radical prostatectomy Scheduled | Carcinoma of bladder TNM clinical staging | Cystectomy Scheduled
Item
patients with histologically proven prostate cancer (t1-2n0m0 gleason score 6-10) scheduled for radical prostatectomy or patients with histologically proven bladder cancer (t1-3bn0m0g3) scheduled for cystectomy
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C3203027 (UMLS CUI [2,2])
C0194810 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0699885 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
C0010651 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
Informed Consent
Item
written informed consent to participate in this trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contraindication Magnetic Resonance Imaging | Artificial cardiac pacemaker | Metallic implant | Claustrophobia
Item
patients with contraindications for mri (e.g. pacemaker, metal implants, claustrophobia).
boolean
C0522473 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
Status Cardiovascular Critical | At risk Heart Decompensation | Status post Administration USPIO
Item
patients in a critical cardiovascular state, with risk of decompensation after administration of the uspio contrast agent.
boolean
C0449438 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C1511545 (UMLS CUI [1,3])
C1444641 (UMLS CUI [2,1])
C1961112 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0386370 (UMLS CUI [3,3])
Hemochromatosis | Dextran allergy | Compound iron preparations allergy
Item
patients with hemochromatosis or an allergy to dextran or iron compounds.
boolean
C0018995 (UMLS CUI [1])
C0571755 (UMLS CUI [2])
C0571799 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gadolinium Before MRI | Ferric oxide Particles Before MRI
Item
patients who have received gadolinium complexes within 2 days or iron oxide particles within 7 days before mri.
boolean
C0016911 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0060240 (UMLS CUI [2,1])
C0597177 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
Chemotherapy Before Operative Surgical Procedures | Therapeutic radiology procedure Before Operative Surgical Procedures
Item
patients who underwent chemotherapy or radiotherapy before surgery.
boolean
C0392920 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Compliance behavior Inconsistent Study Execution
Item
patients whose degree of cooperation is incompatible with carrying out the study.
boolean
C1321605 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0681872 (UMLS CUI [1,3])
Medical contraindication Glucagon
Item
patients with contraindications to glucagon administration.
boolean
C1301624 (UMLS CUI [1,1])
C0017687 (UMLS CUI [1,2])
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