ID

31626

Description

Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00924313

Link

https://clinicaltrials.gov/show/NCT00924313

Keywords

Versions (1)
  1. 9/14/18 9/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00924313

English

Eligibility Prostate Cancer NCT00924313

1 forms  
Criteria
Description

Criteria

participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the national institutes of health (nih) clinical center.
Description

Standard of Care Prostatectomy Scheduled | Prostate carcinoma Localized Presumptive

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0033573
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0392752
UMLS CUI [2,3]
C3640893
recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. knowledge of the location of each specimen is required for inclusion.
Description

Adenocarcinoma of prostate Transrectal biopsy | Adenocarcinoma of prostate Sextant biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0401641
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C3846092
participant must be 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
serum creatinine within 1 week prior to magnetic resonance (mr) imaging less than or equal to 1.8mg/dl and epidermal growth factor receptor (egfr) must be greater than 30 ml/min/1.73 m^2
Description

Serum creatinine measurement prior to Magnetic Resonance Imaging | Epidermal Growth Factor Receptor Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C3812682
eastern cooperative oncology group (ecog) performance score of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
ability to provide informed consent. all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy to gadolinium or acetate.
Description

Hypersensitivity Gadolinium | Hypersensitivity Acetate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016911
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0000975
participants for whom participating would significantly delay the scheduled standard of care therapy.
Description

Study Subject Participation Status Causing Delay Standard of Care

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0205421
UMLS CUI [1,4]
C2936643
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
Description

Comorbidity Interferes with Study procedure | Mental condition Interferes with Study procedure | Comorbidity Interferes with Research results | Mental condition Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0184661
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2603343
UMLS CUI [2,4]
C0184661
UMLS CUI [3,1]
C0009488
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
participants with severe claustrophobia.
Description

Claustrophobia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
patients with contraindications to magnetic resonance imaging (mri)
Description

Medical contraindication Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
patients weighing greater than 136 kg (weight limit for scanner table).
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with mri.
Description

Artificial cardiac pacemaker | Aneurysm clip cerebral | Shrapnel injury | Implants Electronic Inconsistent MRI | Metal Inconsistent MRI

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2,1]
C0179977
UMLS CUI [2,2]
C0006104
UMLS CUI [3,1]
C0522670
UMLS CUI [3,2]
C3263723
UMLS CUI [4,1]
C0021102
UMLS CUI [4,2]
C0013850
UMLS CUI [4,3]
C0442809
UMLS CUI [4,4]
C0024485
UMLS CUI [5,1]
C0025552
UMLS CUI [5,2]
C0442809
UMLS CUI [5,3]
C0024485
patients with contraindication to endorectal coil placement
Description

Medical contraindication Placement Coil Endorectal

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0441587
UMLS CUI [1,3]
C1705946
UMLS CUI [1,4]
C0524447
severe hemorrhoids.
Description

Hemorrhoids Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0019112
UMLS CUI [1,2]
C0205082
surgically absent rectum.
Description

Rectum Absent Surgical

Data type

boolean

Alias
UMLS CUI [1,1]
C0034896
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0543467
other medical conditions deemed by the principal investigator (pi) or associates to make the patient ineligible for protocol procedures.
Description

Other medical condition Study Subject Participation Status Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1512714
patients who have previously received radiation therapy to the pelvis.
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
patients who have received androgen deprivation therapy.
Description

Antiandrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279492
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Similar models

Eligibility Prostate Cancer NCT00924313

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Standard of Care Prostatectomy Scheduled | Prostate carcinoma Localized Presumptive
Item
participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the national institutes of health (nih) clinical center.
boolean
C2936643 (UMLS CUI [1,1])
C0033573 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0600139 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C3640893 (UMLS CUI [2,3])
Adenocarcinoma of prostate Transrectal biopsy | Adenocarcinoma of prostate Sextant biopsy
Item
recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. knowledge of the location of each specimen is required for inclusion.
boolean
C0007112 (UMLS CUI [1,1])
C0401641 (UMLS CUI [1,2])
C0007112 (UMLS CUI [2,1])
C3846092 (UMLS CUI [2,2])
Age
Item
participant must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Serum creatinine measurement prior to Magnetic Resonance Imaging | Epidermal Growth Factor Receptor Measurement
Item
serum creatinine within 1 week prior to magnetic resonance (mr) imaging less than or equal to 1.8mg/dl and epidermal growth factor receptor (egfr) must be greater than 30 ml/min/1.73 m^2
boolean
C0201976 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C3812682 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
ability to provide informed consent. all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Gadolinium | Hypersensitivity Acetate
Item
known allergy to gadolinium or acetate.
boolean
C0020517 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0000975 (UMLS CUI [2,2])
Study Subject Participation Status Causing Delay Standard of Care
Item
participants for whom participating would significantly delay the scheduled standard of care therapy.
boolean
C2348568 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,3])
C2936643 (UMLS CUI [1,4])
Comorbidity Interferes with Study procedure | Mental condition Interferes with Study procedure | Comorbidity Interferes with Research results | Mental condition Interferes with Research results
Item
participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
C0184661 (UMLS CUI [2,4])
C0009488 (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])
Claustrophobia Severe
Item
participants with severe claustrophobia.
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Magnetic Resonance Imaging
Item
patients with contraindications to magnetic resonance imaging (mri)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Body Weight
Item
patients weighing greater than 136 kg (weight limit for scanner table).
boolean
C0005910 (UMLS CUI [1])
Artificial cardiac pacemaker | Aneurysm clip cerebral | Shrapnel injury | Implants Electronic Inconsistent MRI | Metal Inconsistent MRI
Item
patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with mri.
boolean
C0030163 (UMLS CUI [1])
C0179977 (UMLS CUI [2,1])
C0006104 (UMLS CUI [2,2])
C0522670 (UMLS CUI [3,1])
C3263723 (UMLS CUI [3,2])
C0021102 (UMLS CUI [4,1])
C0013850 (UMLS CUI [4,2])
C0442809 (UMLS CUI [4,3])
C0024485 (UMLS CUI [4,4])
C0025552 (UMLS CUI [5,1])
C0442809 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
Medical contraindication Placement Coil Endorectal
Item
patients with contraindication to endorectal coil placement
boolean
C1301624 (UMLS CUI [1,1])
C0441587 (UMLS CUI [1,2])
C1705946 (UMLS CUI [1,3])
C0524447 (UMLS CUI [1,4])
Hemorrhoids Severe
Item
severe hemorrhoids.
boolean
C0019112 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Rectum Absent Surgical
Item
surgically absent rectum.
boolean
C0034896 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Other medical condition Study Subject Participation Status Ineligible
Item
other medical conditions deemed by the principal investigator (pi) or associates to make the patient ineligible for protocol procedures.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
Radiotherapy to pelvis
Item
patients who have previously received radiation therapy to the pelvis.
boolean
C1536155 (UMLS CUI [1])
Antiandrogen therapy
Item
patients who have received androgen deprivation therapy.
boolean
C0279492 (UMLS CUI [1])
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