ID

17177

Beschreibung

Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00499421

Link

https://clinicaltrials.gov/show/NCT00499421

Stichworte

Versionen (1)
  1. 30.08.16 30.08.16 -
Hochgeladen am

30. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00499421

Englisch

Eligibility Prostate Cancer NCT00499421

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with pathologic diagnosis of prostate cancer.
Beschreibung

prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
2. patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.
Beschreibung

external beam radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0419095
3. patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.
Beschreibung

transrectal or transperineal implantation of fiducial markers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826325
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0205518
UMLS CUI [2,1]
C2826325
UMLS CUI [2,2]
C0021107
UMLS CUI [2,3]
C0205500
4. patients must be able to tolerate frequent (e.g. three ct scans per week) ct scanning.
Beschreibung

CT scan

Datentyp

boolean

Alias
UMLS CUI [1]
C0040405
5. patients must be able to lie flat and still for the duration of the fiducial-based localization and ct scanning sessions.
Beschreibung

able to lie flat and still

Datentyp

boolean

Alias
UMLS CUI [1]
C0560840
6. patients must have anatomy that will allow an adequate pelvic image on portal imaging and ct scanning.
Beschreibung

adequate pelvic image on portal imaging and ct scanning

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3703842
UMLS CUI [1,2]
C0205411
7. if patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.
Beschreibung

hormone therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
8. patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.
Beschreibung

hormonal therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
9. patients must understand and sign informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.
Beschreibung

patients not candidates for trans-rectal prostate biopsy or cannot tolerate placement of fiducial prostate markers

Datentyp

boolean

Alias
UMLS CUI [1]
C0401641
UMLS CUI [2,1]
C2826325
UMLS CUI [2,2]
C0021107
2. patients with an estimated prostate volume of less than 20 cc.
Beschreibung

prostate volume

Datentyp

boolean

Alias
UMLS CUI [1]
C1441416
3. patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.
Beschreibung

prostate surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0194790
4. patients who have had previous radiation therapy to the pelvis.
Beschreibung

radiation therapy to the pelvis

Datentyp

boolean

Alias
UMLS CUI [1]
C0747411
5. patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).
Beschreibung

prostate brachytherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0854662
6. patients with a body habitus that the ct bore of the ct/linac treatment machine cannot accommodate (i.e. height greater than 6' 3" or body weight greater than 300 pounds).
Beschreibung

Height, body weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0005910
7. patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.
Beschreibung

anticoagulants

Datentyp

boolean

Alias
UMLS CUI [1]
C0003280
8. patients with hip prostheses will not be eligible.
Beschreibung

hip prosthesis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019560
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00499421

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer
Item
1. patients with pathologic diagnosis of prostate cancer.
boolean
C0600139 (UMLS CUI [1])
external beam radiation
Item
2. patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.
boolean
C0419095 (UMLS CUI [1])
transrectal or transperineal implantation of fiducial markers
Item
3. patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.
boolean
C2826325 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0205518 (UMLS CUI [1,3])
C2826325 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
C0205500 (UMLS CUI [2,3])
CT scan
Item
4. patients must be able to tolerate frequent (e.g. three ct scans per week) ct scanning.
boolean
C0040405 (UMLS CUI [1])
able to lie flat and still
Item
5. patients must be able to lie flat and still for the duration of the fiducial-based localization and ct scanning sessions.
boolean
C0560840 (UMLS CUI [1])
adequate pelvic image on portal imaging and ct scanning
Item
6. patients must have anatomy that will allow an adequate pelvic image on portal imaging and ct scanning.
boolean
C3703842 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
hormone therapy
Item
7. if patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.
boolean
C0279025 (UMLS CUI [1])
hormonal therapy
Item
8. patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.
boolean
C0279025 (UMLS CUI [1])
Informed Consent
Item
9. patients must understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients not candidates for trans-rectal prostate biopsy or cannot tolerate placement of fiducial prostate markers
Item
1. patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.
boolean
C0401641 (UMLS CUI [1])
C2826325 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
prostate volume
Item
2. patients with an estimated prostate volume of less than 20 cc.
boolean
C1441416 (UMLS CUI [1])
prostate surgery
Item
3. patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.
boolean
C0194790 (UMLS CUI [1])
radiation therapy to the pelvis
Item
4. patients who have had previous radiation therapy to the pelvis.
boolean
C0747411 (UMLS CUI [1])
prostate brachytherapy
Item
5. patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).
boolean
C0854662 (UMLS CUI [1])
Height, body weight
Item
6. patients with a body habitus that the ct bore of the ct/linac treatment machine cannot accommodate (i.e. height greater than 6' 3" or body weight greater than 300 pounds).
boolean
C0005890 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
anticoagulants
Item
7. patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.
boolean
C0003280 (UMLS CUI [1])
hip prosthesis
Item
8. patients with hip prostheses will not be eligible.
boolean
C0019560 (UMLS CUI [1])
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