ID

38145

Description

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

Link

https://clinicaltrials.gov/show/NCT01714128

Keywords

Versions (1)
  1. 9/22/19 9/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01714128

English

Eligibility Breast Cancer NCT01714128

1 forms  
Inclusion Criteria
Description

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Measurable Disease | Bone lesion

Data type

boolean

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

Age

Data type

boolean

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

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

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Cancer Other

Data type

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.
Description

F-18 FES PET/CT scan Scheduled Unsuccessful

Data type

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.
Description

Treatment Cancer Other | Exception Skin carcinoma

Data type

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
Description

Chemotherapy Primary treatment Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0205539
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Similar models

Eligibility Breast Cancer NCT01714128

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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