ID

36897

Beschreibung

A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02424513

Link

https://clinicaltrials.gov/show/NCT02424513

Stichworte

Versionen (1)
  1. 19.06.19 19.06.19 -
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See clinicaltrials.gov

Hochgeladen am

19. Juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02424513

Englisch

Eligibility Prostate Cancer NCT02424513

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological diagnosis of prostate adenocarcinoma.
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
2. patients considered candidates for radical prostatectomy and pelvic lymph node dissection. these patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection.
Beschreibung

Patients Appropriate Radical prostatectomy | Patients Appropriate Pelvic lymphadenectomy | Secondary malignant neoplasm of lymph node Imaging | Secondary malignant neoplasm of lymph node Absent Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0194810
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0193883
UMLS CUI [3,1]
C0686619
UMLS CUI [3,2]
C0011923
UMLS CUI [4,1]
C0686619
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0011923
3. patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the briganti nomogram.
Beschreibung

High risk of Secondary malignant neoplasm of lymph node Pelvic | Risk Percentage Lymph Node Involvement Nomogram

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0686619
UMLS CUI [1,3]
C0030797
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0806692
UMLS CUI [2,4]
C1450294
4. age ≥ 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. ability to understand and willingness to sign irb approved consent form
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
6. for men of child-producing potential, the use of effective contraceptive methods during the study.
Beschreibung

Male fertility Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1955321
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, [89]zr-df-iab2m pet/ct and the surgical resection or biopsy procedures used for the study evaluation.
Beschreibung

Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Therapies, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0949266
2. unwillingness or inability to comply with procedures required in this protocol.
Beschreibung

Protocol Compliance Unwilling | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
3. other cancers that might potentially interfere with the reading and interpretation of [89]zr-df-iab2m pet/ct scans.
Beschreibung

Cancer Other | Interference Interpretation Zirconium Zr 89 Df-IAB2M PET/CT scan

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0459471
UMLS CUI [2,3]
C3827037
UMLS CUI [2,4]
C1699633
4. patients who are currently receiving any other investigational agent.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
5. patients who have had or are currently receiving androgen deprivation therapy
Beschreibung

Antiandrogen therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279492
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02424513

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
1. histological diagnosis of prostate adenocarcinoma.
boolean
C0007112 (UMLS CUI [1])
Patients Appropriate Radical prostatectomy | Patients Appropriate Pelvic lymphadenectomy | Secondary malignant neoplasm of lymph node Imaging | Secondary malignant neoplasm of lymph node Absent Imaging
Item
2. patients considered candidates for radical prostatectomy and pelvic lymph node dissection. these patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0193883 (UMLS CUI [2,3])
C0686619 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
C0686619 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0011923 (UMLS CUI [4,3])
High risk of Secondary malignant neoplasm of lymph node Pelvic | Risk Percentage Lymph Node Involvement Nomogram
Item
3. patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the briganti nomogram.
boolean
C0332167 (UMLS CUI [1,1])
C0686619 (UMLS CUI [1,2])
C0030797 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0806692 (UMLS CUI [2,3])
C1450294 (UMLS CUI [2,4])
Age
Item
4. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
5. ability to understand and willingness to sign irb approved consent form
boolean
C0021430 (UMLS CUI [1])
Male fertility Contraceptive methods
Item
6. for men of child-producing potential, the use of effective contraceptive methods during the study.
boolean
C1955321 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Operative Surgical Procedures | Chemotherapy | Therapies, Investigational
Item
1. treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, [89]zr-df-iab2m pet/ct and the surgical resection or biopsy procedures used for the study evaluation.
boolean
C1522449 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
2. unwillingness or inability to comply with procedures required in this protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Cancer Other | Interference Interpretation Zirconium Zr 89 Df-IAB2M PET/CT scan
Item
3. other cancers that might potentially interfere with the reading and interpretation of [89]zr-df-iab2m pet/ct scans.
boolean
C1707251 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C0459471 (UMLS CUI [2,2])
C3827037 (UMLS CUI [2,3])
C1699633 (UMLS CUI [2,4])
Investigational New Drugs
Item
4. patients who are currently receiving any other investigational agent.
boolean
C0013230 (UMLS CUI [1])
Antiandrogen therapy
Item
5. patients who have had or are currently receiving androgen deprivation therapy
boolean
C0279492 (UMLS CUI [1])
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