ID

26087

Description

Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities; ODM derived from: https://clinicaltrials.gov/show/NCT00606931

Lien

https://clinicaltrials.gov/show/NCT00606931

Mots-clés

Versions (1)
  1. 09/10/2017 09/10/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

9 octobre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00606931

Anglais

Eligibility Breast Cancer NCT00606931

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individuals aged 25 years or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
individuals who have at least one breast imaging finding requiring biopsy, specifically:
Description

Breast Imaging finding Quantity | Biopsy Patient need for

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C1287399
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0686904
individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or mri (as per acr birads™ 4c or 5) and requiring biopsy confirmation or o individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution fdg pet scan
Description

Abnormality of the breast Suspicious for Malignancy Imaging | Abnormality of the breast Suggestive of Malignant Neoplasm Imaging | Mammography | Ultrasonography | MRI | BIRADS | Biopsy Patient need for | Breast Carcinoma | FDG-PET Scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C4025829
UMLS CUI [1,2]
C4050405
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C4025829
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0006826
UMLS CUI [2,4]
C0011923
UMLS CUI [3]
C0024671
UMLS CUI [4]
C0041618
UMLS CUI [5]
C0024485
UMLS CUI [6]
C1511314
UMLS CUI [7,1]
C0005558
UMLS CUI [7,2]
C0686904
UMLS CUI [8]
C0678222
UMLS CUI [9]
C3641247
individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.
Description

Imaging Work up | Abnormality of the breast Mammography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0750430
UMLS CUI [2,1]
C4025829
UMLS CUI [2,2]
C0024671
individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or mri if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or mri if not detectable on mammography) is more than 1 cm. (note: the study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, ct, or mri, if the lesion is not detectable or measurable on mammography.)
Description

Tumor size Suspected | Lesion Mammography | Lesion Ultrasonography | Lesion MRI | Biopsy | CT

Type de données

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0024671
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0024485
UMLS CUI [5]
C0005558
UMLS CUI [6]
C0040405
individuals who have agreed to participate in the study and who have signed study-specific informed consent
Description

Study Subject Participation Status Agreement | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0680240
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are or may be pregnant
Description

Pregnancy | Possible pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
women who are currently lactating or discontinued breastfeeding < 2 months prior to the study
Description

Breast Feeding | Breast Feeding Discontinued Recently

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0332185
age less than 25 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
individuals with breast implant(s) in the breast containing the lesion of interest
Description

Breast implant | Breast Containing Lesion

Type de données

boolean

Alias
UMLS CUI [1]
C0179412
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0221198
individuals who are scheduled for a sentinel node procedure using radioactive tc-99m within 24 hours of pet-guided biopsy
Description

Sentinel Lymph Node Biopsy Tc-99m Scheduled | PET Biopsy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C0303611
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0032743
UMLS CUI [2,2]
C0005558
patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure
Description

Medical contraindication Core biopsy | Medical contraindication Invasive procedure | Blood Coagulation Disorders | Communicable Disease | Anticoagulants Discontinue Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C4048276
UMLS CUI [3]
C0005779
UMLS CUI [4]
C0009450
UMLS CUI [5,1]
C0003280
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0558080
individuals with type i or poorly controlled type ii diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
individuals with a blood glucose level that is above 140 mg/dl at the time of pem imaging
Description

Blood glucose measurement | Positron Emission Mammography

Type de données

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2]
C3897879
inability to provide informed consent
Description

Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
individuals who have had surgery on the study breast(s) within the past 12 months
Description

Operative Surgical Procedure Breast Involved

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1314939
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Similar models

Eligibility Breast Cancer NCT00606931

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
individuals aged 25 years or older
boolean
C0001779 (UMLS CUI [1])
Breast Imaging finding Quantity | Biopsy Patient need for
Item
individuals who have at least one breast imaging finding requiring biopsy, specifically:
boolean
C0006141 (UMLS CUI [1,1])
C1287399 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Abnormality of the breast Suspicious for Malignancy Imaging | Abnormality of the breast Suggestive of Malignant Neoplasm Imaging | Mammography | Ultrasonography | MRI | BIRADS | Biopsy Patient need for | Breast Carcinoma | FDG-PET Scan
Item
individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or mri (as per acr birads™ 4c or 5) and requiring biopsy confirmation or o individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution fdg pet scan
boolean
C4025829 (UMLS CUI [1,1])
C4050405 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C4025829 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0011923 (UMLS CUI [2,4])
C0024671 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1511314 (UMLS CUI [6])
C0005558 (UMLS CUI [7,1])
C0686904 (UMLS CUI [7,2])
C0678222 (UMLS CUI [8])
C3641247 (UMLS CUI [9])
Imaging Work up | Abnormality of the breast Mammography
Item
individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.
boolean
C0011923 (UMLS CUI [1,1])
C0750430 (UMLS CUI [1,2])
C4025829 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
Tumor size Suspected | Lesion Mammography | Lesion Ultrasonography | Lesion MRI | Biopsy | CT
Item
individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or mri if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or mri if not detectable on mammography) is more than 1 cm. (note: the study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, ct, or mri, if the lesion is not detectable or measurable on mammography.)
boolean
C0475440 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0005558 (UMLS CUI [5])
C0040405 (UMLS CUI [6])
Study Subject Participation Status Agreement | Informed Consent
Item
individuals who have agreed to participate in the study and who have signed study-specific informed consent
boolean
C2348568 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Possible pregnancy
Item
women who are or may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Breast Feeding | Breast Feeding Discontinued Recently
Item
women who are currently lactating or discontinued breastfeeding < 2 months prior to the study
boolean
C0006147 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Age
Item
age less than 25 years
boolean
C0001779 (UMLS CUI [1])
Breast implant | Breast Containing Lesion
Item
individuals with breast implant(s) in the breast containing the lesion of interest
boolean
C0179412 (UMLS CUI [1])
C0006141 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
Sentinel Lymph Node Biopsy Tc-99m Scheduled | PET Biopsy
Item
individuals who are scheduled for a sentinel node procedure using radioactive tc-99m within 24 hours of pet-guided biopsy
boolean
C0796693 (UMLS CUI [1,1])
C0303611 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0032743 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Medical contraindication Core biopsy | Medical contraindication Invasive procedure | Blood Coagulation Disorders | Communicable Disease | Anticoagulants Discontinue Unwilling
Item
patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure
boolean
C1301624 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C4048276 (UMLS CUI [2,2])
C0005779 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
C0003280 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
individuals with type i or poorly controlled type ii diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Blood glucose measurement | Positron Emission Mammography
Item
individuals with a blood glucose level that is above 140 mg/dl at the time of pem imaging
boolean
C0392201 (UMLS CUI [1])
C3897879 (UMLS CUI [2])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Operative Surgical Procedure Breast Involved
Item
individuals who have had surgery on the study breast(s) within the past 12 months
boolean
C0543467 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
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