ID

15133

Description

Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02335671

Link

https://clinicaltrials.gov/show/NCT02335671

Keywords

Versions (1)
  1. 5/18/16 5/18/16 -
Uploaded on

May 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Early Stage Breast Cancer NCT02335671

English

Eligibility Early Stage Breast Cancer NCT02335671

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
participants must have a pre-operative standard mammogram with or without ultrasound. these may be performed at outside institutions.
Description

Mammography Preoperative | Ultrasonics (sound)

Data type

boolean

Alias
UMLS CUI [1,1]
C0024671
UMLS CUI [1,2]
C0445204
UMLS CUI [2]
C1456803
participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. if biopsy was done at an outside hospital, pathology will be reviewed at bwh/dfci.
Description

Carcinoma breast stage I | Breast cancer stage II | Biopsy | Pathology procedure Dana-Farber/Harvard Cancer Center

Data type

boolean

Alias
UMLS CUI [1]
C0278485
UMLS CUI [2]
C0278486
UMLS CUI [3]
C0005558
UMLS CUI [4,1]
C0919386
UMLS CUI [4,2]
C1511716
participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for bcs, and the ability to undergo standard radiation therapy post-operatively).
Description

Local Therapy | Breast-Conserving Surgery | Neoplasm Breast size Ratio | Therapeutic radiology procedure Postoperative

Data type

boolean

Alias
UMLS CUI [1]
C1517925
UMLS CUI [2]
C0917927
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0425782
UMLS CUI [3,3]
C0456603
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0231287
patient must meet standard mri guidelines and be able and willing to undergo mri
Description

Magnetic Resonance Imaging Guidelines | Ability Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0162791
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0024485
age ≥18 years and < 75.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand and the willingness to sign a written informed consent document.
Description

Comprehension Willing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with a known brca 1 or 2 mutation.
Description

BRCA1 gene Mutation | BRCA2 gene Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0376571
UMLS CUI [1,2]
C0026882
UMLS CUI [2,1]
C0598034
UMLS CUI [2,2]
C0026882
participants with known li-fraumeni or cowden's disease.
Description

Li-Fraumeni Syndrome | Cowden disease

Data type

boolean

Alias
UMLS CUI [1]
C0085390
UMLS CUI [2]
C0018553
participants with prior mantle radiation.
Description

Mantle field irradiation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1168306
UMLS CUI [1,2]
C0205156
participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
Description

Locally advanced breast cancer | Inflammatory Breast Carcinoma | Malignant neoplasm of skin

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278601
UMLS CUI [3]
C0007114
participants who are pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy.
Description

Study Subject Participation Status | Therapeutic procedure Preoperative Clinical Trials | Neoadjuvant Therapy Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0445204
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C3665472
participants with known active collagen vascular disease.
Description

Collagen-vascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0262428
participants with prior history of ipsilateral breast carcinoma.
Description

Malignant neoplasm of breast Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0441989
patients who have biopsy confirmed multi-centric disease.
Description

Multicentric Breast Carcinoma | Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C2986664
UMLS CUI [2]
C0005558
participants who have documented contra-indications for contrast-enhanced mri, including but not limited to renal failure.
Description

Medical contraindication Contrast-enhanced Magnetic Resonance Imaging | Medical contraindication Kidney Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1707501
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0035078
participants who exceed the weight limit for the surgical table at amigo, 350 lbs or who will not fit into the 70 cm diameter bore of the mri scanner at amigo or the 60 cm diameter bore of the pre-procedure imaging mri scanner.
Description

Patient Inappropriate | Body Weight | Magnetic Resonance Imaging | Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [2]
C0005910
UMLS CUI [3]
C0024485
UMLS CUI [4]
C1301886
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Similar models

Eligibility Early Stage Breast Cancer NCT02335671

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
patients must be female
boolean
C0079399 (UMLS CUI [1])
Mammography Preoperative | Ultrasonics (sound)
Item
participants must have a pre-operative standard mammogram with or without ultrasound. these may be performed at outside institutions.
boolean
C0024671 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C1456803 (UMLS CUI [2])
Carcinoma breast stage I | Breast cancer stage II | Biopsy | Pathology procedure Dana-Farber/Harvard Cancer Center
Item
participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. if biopsy was done at an outside hospital, pathology will be reviewed at bwh/dfci.
boolean
C0278485 (UMLS CUI [1])
C0278486 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
C0919386 (UMLS CUI [4,1])
C1511716 (UMLS CUI [4,2])
Local Therapy | Breast-Conserving Surgery | Neoplasm Breast size Ratio | Therapeutic radiology procedure Postoperative
Item
participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for bcs, and the ability to undergo standard radiation therapy post-operatively).
boolean
C1517925 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C0027651 (UMLS CUI [3,1])
C0425782 (UMLS CUI [3,2])
C0456603 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4,1])
C0231287 (UMLS CUI [4,2])
Magnetic Resonance Imaging Guidelines | Ability Magnetic Resonance Imaging
Item
patient must meet standard mri guidelines and be able and willing to undergo mri
boolean
C0024485 (UMLS CUI [1,1])
C0162791 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Age
Item
age ≥18 years and < 75.
boolean
C0001779 (UMLS CUI [1])
Comprehension Willing Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0162340 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
BRCA1 gene Mutation | BRCA2 gene Mutation
Item
participants with a known brca 1 or 2 mutation.
boolean
C0376571 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0598034 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
Li-Fraumeni Syndrome | Cowden disease
Item
participants with known li-fraumeni or cowden's disease.
boolean
C0085390 (UMLS CUI [1])
C0018553 (UMLS CUI [2])
Mantle field irradiation Previous
Item
participants with prior mantle radiation.
boolean
C1168306 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Locally advanced breast cancer | Inflammatory Breast Carcinoma | Malignant neoplasm of skin
Item
participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
boolean
C3495949 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C0007114 (UMLS CUI [3])
Pregnancy
Item
participants who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Therapeutic procedure Preoperative Clinical Trials | Neoadjuvant Therapy Chemotherapy
Item
participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
Collagen-vascular disease
Item
participants with known active collagen vascular disease.
boolean
C0262428 (UMLS CUI [1])
Malignant neoplasm of breast Ipsilateral
Item
participants with prior history of ipsilateral breast carcinoma.
boolean
C0006142 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
Multicentric Breast Carcinoma | Biopsy
Item
patients who have biopsy confirmed multi-centric disease.
boolean
C2986664 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
Medical contraindication Contrast-enhanced Magnetic Resonance Imaging | Medical contraindication Kidney Failure
Item
participants who have documented contra-indications for contrast-enhanced mri, including but not limited to renal failure.
boolean
C1301624 (UMLS CUI [1,1])
C1707501 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035078 (UMLS CUI [2,2])
Patient Inappropriate | Body Weight | Magnetic Resonance Imaging | Diameter
Item
participants who exceed the weight limit for the surgical table at amigo, 350 lbs or who will not fit into the 70 cm diameter bore of the mri scanner at amigo or the 60 cm diameter bore of the pre-procedure imaging mri scanner.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0005910 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C1301886 (UMLS CUI [4])
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