ID

36963

Descrição

Gallium-68 Citrate PET Used in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02391025

Link

https://clinicaltrials.gov/show/NCT02391025

Palavras-chave

Versões (1)
  1. 24/06/2019 24/06/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de junho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02391025

Inglês

Eligibility Prostatic Neoplasms NCT02391025

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male patients with histologically confirmed prostate cancer
Descrição

Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0600139
patients must have castrate levels of testosterone (< 50 ng/dl) on lhrh analogue or have had prior orchiectomy.
Descrição

Castration Levels of Testosterone | Luteinizing Hormone-releasing Hormone Agonist | Orchiectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4289828
UMLS CUI [2]
C1518041
UMLS CUI [3]
C0029189
presence of one or more metastases by standard radiographic scans including cross-sectional imaging of the chest/abdomen/pelvis and whole body bone scan that is safely accessible to tumor biopsy in the judgment of treating clinician and/or interventional radiology
Descrição

Neoplasm Metastasis Quantity Radiography | Cross-sectional imaging Chest | Cross-sectional imaging Abdomen | Cross-sectional imaging Pelvis | Whole body bone scan | Tumor Biopsy | Interventional radiology

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C3824793
UMLS CUI [2,2]
C0817096
UMLS CUI [3,1]
C3824793
UMLS CUI [3,2]
C0000726
UMLS CUI [4,1]
C3824793
UMLS CUI [4,2]
C0030797
UMLS CUI [5]
C3863086
UMLS CUI [6,1]
C0027651
UMLS CUI [6,2]
C0005558
UMLS CUI [7]
C0034602
evidence of disease progression by pcwg2 criteria during or within 4 weeks following treatment discontinuation with potent androgen signaling inhibitor, including abiraterone, enzalutamide, arn-509, or a combination.
Descrição

Disease Progression | Therapeutic procedure Discontinuation | Androgen Antagonists | abiraterone | enzalutamide | ARN-509 | Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [3]
C0002842
UMLS CUI [4]
C0754011
UMLS CUI [5]
C3496793
UMLS CUI [6]
C2985183
UMLS CUI [7]
C0009429
patients must be either receiving or within 4 weeks of discontinuation of androgen signaling inhibitor at the time of pet imaging and tumor biopsy.
Descrição

Androgen Antagonists | Androgen Antagonists Discontinuation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2,1]
C0002842
UMLS CUI [2,2]
C1444662
age 18 years or older at the time of study entry
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
platelets >75,000/μl and pt or inr and a ptt < 1.5 times the institutional uln within 14 days prior to biopsy.
Descrição

Platelet Count measurement | Prothrombin time assay | International Normalized Ratio | Activated Partial Thromboplastin Time measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0525032
UMLS CUI [4]
C0030605
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
intervening systemic therapy between discontinuation of androgen signaling inhibitor and planned date of gallium citrate pet.
Descrição

Systemic therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1515119
history of radiation therapy to the target metastatic lesion selected for tumor biopsy
Descrição

Therapeutic radiology procedure Targeting Metastatic Lesion | Metastatic Lesion Tumor Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C1513183
UMLS CUI [2,1]
C1513183
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C0005558
contra-indication to biopsy including uncontrolled bleeding diathesis.
Descrição

Medical contraindication Biopsy | Bleeding tendency Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1458140
UMLS CUI [2,2]
C0205318
active infection within 14 days of study enrollment
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
contraindications for mri (for patients undergoing pet/mr study), including presence of pacemaker, aneurysm clip, implanted device, or severe claustrophobia
Descrição

Medical contraindication MRI | PET and MRI | Artificial cardiac pacemaker | Aneurysm clip | Implants | Claustrophobia Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C3641326
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0179977
UMLS CUI [5]
C0021102
UMLS CUI [6,1]
C0008909
UMLS CUI [6,2]
C0205082
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Similar models

Eligibility Prostatic Neoplasms NCT02391025

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
male patients with histologically confirmed prostate cancer
boolean
C0600139 (UMLS CUI [1])
Castration Levels of Testosterone | Luteinizing Hormone-releasing Hormone Agonist | Orchiectomy
Item
patients must have castrate levels of testosterone (< 50 ng/dl) on lhrh analogue or have had prior orchiectomy.
boolean
C4289828 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0029189 (UMLS CUI [3])
Neoplasm Metastasis Quantity Radiography | Cross-sectional imaging Chest | Cross-sectional imaging Abdomen | Cross-sectional imaging Pelvis | Whole body bone scan | Tumor Biopsy | Interventional radiology
Item
presence of one or more metastases by standard radiographic scans including cross-sectional imaging of the chest/abdomen/pelvis and whole body bone scan that is safely accessible to tumor biopsy in the judgment of treating clinician and/or interventional radiology
boolean
C0027627 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C3824793 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C3824793 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
C3824793 (UMLS CUI [4,1])
C0030797 (UMLS CUI [4,2])
C3863086 (UMLS CUI [5])
C0027651 (UMLS CUI [6,1])
C0005558 (UMLS CUI [6,2])
C0034602 (UMLS CUI [7])
Disease Progression | Therapeutic procedure Discontinuation | Androgen Antagonists | abiraterone | enzalutamide | ARN-509 | Combined Modality Therapy
Item
evidence of disease progression by pcwg2 criteria during or within 4 weeks following treatment discontinuation with potent androgen signaling inhibitor, including abiraterone, enzalutamide, arn-509, or a combination.
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0002842 (UMLS CUI [3])
C0754011 (UMLS CUI [4])
C3496793 (UMLS CUI [5])
C2985183 (UMLS CUI [6])
C0009429 (UMLS CUI [7])
Androgen Antagonists | Androgen Antagonists Discontinuation
Item
patients must be either receiving or within 4 weeks of discontinuation of androgen signaling inhibitor at the time of pet imaging and tumor biopsy.
boolean
C0002842 (UMLS CUI [1])
C0002842 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Age
Item
age 18 years or older at the time of study entry
boolean
C0001779 (UMLS CUI [1])
Platelet Count measurement | Prothrombin time assay | International Normalized Ratio | Activated Partial Thromboplastin Time measurement
Item
platelets >75,000/μl and pt or inr and a ptt < 1.5 times the institutional uln within 14 days prior to biopsy.
boolean
C0032181 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Systemic therapy
Item
intervening systemic therapy between discontinuation of androgen signaling inhibitor and planned date of gallium citrate pet.
boolean
C1515119 (UMLS CUI [1])
Therapeutic radiology procedure Targeting Metastatic Lesion | Metastatic Lesion Tumor Biopsy
Item
history of radiation therapy to the target metastatic lesion selected for tumor biopsy
boolean
C1522449 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C1513183 (UMLS CUI [1,3])
C1513183 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
Medical contraindication Biopsy | Bleeding tendency Uncontrolled
Item
contra-indication to biopsy including uncontrolled bleeding diathesis.
boolean
C1301624 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1458140 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Communicable Disease
Item
active infection within 14 days of study enrollment
boolean
C0009450 (UMLS CUI [1])
Medical contraindication MRI | PET and MRI | Artificial cardiac pacemaker | Aneurysm clip | Implants | Claustrophobia Severe
Item
contraindications for mri (for patients undergoing pet/mr study), including presence of pacemaker, aneurysm clip, implanted device, or severe claustrophobia
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3641326 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0179977 (UMLS CUI [4])
C0021102 (UMLS CUI [5])
C0008909 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
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