ID

38145

Beschreibung

FES-PET for Patients Treated on NCI Protocol 8762; ODM derived from: https://clinicaltrials.gov/show/NCT01714128

Link

https://clinicaltrials.gov/show/NCT01714128

Stichworte

Versionen (1)
  1. 22.09.19 22.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. September 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01714128

Englisch

Eligibility Breast Cancer NCT01714128

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have agreed and signed consent to participate in nci protocol 8762 and be scheduled to receive the first dose of mk-2206 in a minimum of 48 hours and a maximum of 30 days after the fes-pet/ct imaging.
Beschreibung

Consent Clinical trial protocol Specified | MK 2206 Dose Scheduled | Status post F-18 FES PET/CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C2599718
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C2933427
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1831937
UMLS CUI [3,3]
C1699633
note: patients need to be on the endocrine agent for at least 1 week prior to the fes-pet/ct imaging.
Beschreibung

Antineoplastic Endocrinal Agent prior to F-18 FES PET/CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0282559
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1831937
UMLS CUI [1,4]
C1699633
2. patients must have measurable disease (defined by recist criteria) or the presence of bone lesions if there is no measurable lesion.
Beschreibung

Measurable Disease | Bone lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0238792
3. patient must be ≥ 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. patient must be able to tolerate and have no contraindication to fes-pet/ct imaging.
Beschreibung

Ability Receive F-18 FES PET/CT scan | Medical contraindication Absent F-18 FES PET/CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1831937
UMLS CUI [1,4]
C1699633
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1831937
UMLS CUI [2,4]
C1699633
5. patient must be able and willing to give informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient must have no other active cancer at the time of study entry.
Beschreibung

Cancer Other

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
2. the research fes-pet/ct scan could not be scheduled more than 48 hours before starting therapy with mk-2206.
Beschreibung

F-18 FES PET/CT scan Scheduled Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1831937
UMLS CUI [1,2]
C1699633
UMLS CUI [1,3]
C0205539
UMLS CUI [1,4]
C1272705
3. patient cannot have received treatment for any other malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
Beschreibung

Treatment Cancer Other | Exception Skin carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
4. patients scheduled to receive chemotherapy as the primary source of treatment
Beschreibung

Chemotherapy Primary treatment Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0205539
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Ähnliche Modelle

Eligibility Breast Cancer NCT01714128

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Consent Clinical trial protocol Specified | MK 2206 Dose Scheduled | Status post F-18 FES PET/CT scan
Item
1. patients must have agreed and signed consent to participate in nci protocol 8762 and be scheduled to receive the first dose of mk-2206 in a minimum of 48 hours and a maximum of 30 days after the fes-pet/ct imaging.
boolean
C1511481 (UMLS CUI [1,1])
C2599718 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C2933427 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1831937 (UMLS CUI [3,2])
C1699633 (UMLS CUI [3,3])
Antineoplastic Endocrinal Agent prior to F-18 FES PET/CT scan
Item
note: patients need to be on the endocrine agent for at least 1 week prior to the fes-pet/ct imaging.
boolean
C0282559 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1831937 (UMLS CUI [1,3])
C1699633 (UMLS CUI [1,4])
Measurable Disease | Bone lesion
Item
2. patients must have measurable disease (defined by recist criteria) or the presence of bone lesions if there is no measurable lesion.
boolean
C1513041 (UMLS CUI [1])
C0238792 (UMLS CUI [2])
Age
Item
3. patient must be ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Ability Receive F-18 FES PET/CT scan | Medical contraindication Absent F-18 FES PET/CT scan
Item
4. patient must be able to tolerate and have no contraindication to fes-pet/ct imaging.
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1831937 (UMLS CUI [1,3])
C1699633 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1831937 (UMLS CUI [2,3])
C1699633 (UMLS CUI [2,4])
Informed Consent
Item
5. patient must be able and willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
1. patient must have no other active cancer at the time of study entry.
boolean
C1707251 (UMLS CUI [1])
F-18 FES PET/CT scan Scheduled Unsuccessful
Item
2. the research fes-pet/ct scan could not be scheduled more than 48 hours before starting therapy with mk-2206.
boolean
C1831937 (UMLS CUI [1,1])
C1699633 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Treatment Cancer Other | Exception Skin carcinoma
Item
3. patient cannot have received treatment for any other malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Chemotherapy Primary treatment Scheduled
Item
4. patients scheduled to receive chemotherapy as the primary source of treatment
boolean
C0392920 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
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