ID

19616

Beskrivning

Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00484614

Länk

https://clinicaltrials.gov/show/NCT00484614

Nyckelord

Versioner (1)
  1. 2017-01-16 2017-01-16 -
Uppladdad den

16 januari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00484614

Engelsk

Eligibility Breast Cancer NCT00484614

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women who are 25 years of age or older
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. newly diagnosed core-biopsy proven breast cancer
Beskrivning

Breast Carcinoma Core needle biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1318309
3. has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any)
Beskrivning

Breast Mammography | Calcification Suspicious magnification view mammogram

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0024671
UMLS CUI [2,1]
C0006660
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C3862899
4. recent clinical breast examination (within prior 3 months)
Beskrivning

Examination of breast Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199850
UMLS CUI [1,2]
C0205210
5. has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings
Beskrivning

work up Mammary Ultrasonography | Mammography | clinical findings

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750430
UMLS CUI [1,2]
C0080264
UMLS CUI [2]
C0024671
UMLS CUI [3]
C0037088
6. has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound
Beskrivning

Percutaneous needle biopsy Findings Suspicious Relevant | Mammography | Physical Examination | Ultrasonography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0558528
UMLS CUI [1,2]
C2607943
UMLS CUI [1,3]
C0750493
UMLS CUI [1,4]
C2347946
UMLS CUI [2]
C0024671
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0041618
7. after full diagnostic workup, participant is likely to be a candidate for breast conserving surgery.
Beskrivning

work up | Indication Breast-Conserving Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0750430
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0917927
8. no contraindications to breast mri:
Beskrivning

Medical contraindication Magnetic resonance imaging of breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0344104
no pacemaker, aneurysm clip, or other implanted magnetic or ferromagnetic device;
Beskrivning

Artificial cardiac pacemaker | Aneurysm clip | Implants Magnetic metal

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0179977
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C0439876
no claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative under her physician's orders;
Beskrivning

Claustrophobia Controlled by Pharmaceutical Preparations | Valium | Ativan | Sedatives

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C0013227
UMLS CUI [2]
C0699187
UMLS CUI [3]
C0699194
UMLS CUI [4]
C0036557
has intravenous access;
Beskrivning

venous access

Datatyp

boolean

Alias
UMLS CUI [1]
C0750164
weight < 300 lbs;
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
physically able to tolerate positioning in the mri scanner.
Beskrivning

Magnetic Resonance Imaging Scanner Positioning Ability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0183115
UMLS CUI [1,3]
C1561964
UMLS CUI [1,4]
C0085732
9. agrees to undergo follow-up mri or pem at 6 months and/or mri-guided vacuum-assisted biopsy, us-guided core biopsy, or pem-guided biopsy if needed based on results of the mri or pem examination
Beskrivning

follow-up Magnetic Resonance Imaging | follow-up Positron Emission Mammography | Vacuum-Assisted Biopsy Magnetic resonance imaging guidance | Ultrasound guided biopsy | Positron Emission Mammography Guidance for biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C3897879
UMLS CUI [3,1]
C1710607
UMLS CUI [3,2]
C0442974
UMLS CUI [4]
C0456900
UMLS CUI [5,1]
C3897879
UMLS CUI [5,2]
C0883092
10. has signed study-specific consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
11. subject agrees to undergo a contrast-enhanced mri and pem scan within five business days of each other, prior to surgery.
Beskrivning

Contrast-enhanced Magnetic Resonance Imaging | Positron Emission Mammography Scan

Datatyp

boolean

Alias
UMLS CUI [1]
C1707501
UMLS CUI [2,1]
C3897879
UMLS CUI [2,2]
C0441633
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. male
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
2. pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
3. active lactation or discontinued breastfeeding < 2 months prior
Beskrivning

Breast Feeding | Breast Feeding Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1444662
4. age less than 25 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. inability to provide informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
6. prior radiation treatment to the affected breast(s)
Beskrivning

Therapeutic radiology procedure Breasts Affected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0392760
7. participant is scheduled for sentinel node procedure using radioactive tc-99m within 24 hours after the scheduled pem flex study
Beskrivning

Sentinel Lymph Node Biopsy Technetium 99m

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C0303611
8. women planning prophylactic mastectomy without histologic confirmation
Beskrivning

Gender Planning Prophylactic mastectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C2191320
9. individuals who are electing to undergo neoadjuvant chemotherapy prior to surgery (note: patients with prior contralateral breast cancer receiving chemoprevention with tamoxifen, arimidex, or other aromatase inhibitor are eligible)
Beskrivning

Neoadjuvant Chemotherapy | Operative Surgical Procedures | Chemoprevention Contralateral breast cancer | Tamoxifen | Arimidex | Aromatase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C0282515
UMLS CUI [3,2]
C1096616
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0878174
UMLS CUI [6]
C0593802
10. individuals who have had surgery on the study breast(s) within the past 12 months
Beskrivning

Operative Surgical Procedure Breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0006141
11. breast implant(s) in any study breast(s)
Beskrivning

Breast implant Breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920135
UMLS CUI [1,2]
C0006141
12. women who have had distant metastatic disease either currently or in the past
Beskrivning

Gender Neoplasm Metastasis Distant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0443203
13. individuals with type i or poorly controlled type ii diabetes mellitus
Beskrivning

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

Datatyp

boolean

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

Blood glucose measurement | Positron Emission Mammography

Datatyp

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2]
C3897879
15. has not had contrast-enhanced breast mri or pem within the past 12 months prior to study enrollment
Beskrivning

Contrast-enhanced Magnetic Resonance Imaging Breast | Positron Emission Mammography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707501
UMLS CUI [1,2]
C0006141
UMLS CUI [2]
C3897879
16. subject is currently enrolled in another breast imaging research study
Beskrivning

Study Subject Participation Status | Breast Imaging

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C0079595
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Similar models

Eligibility Breast Cancer NCT00484614

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. women who are 25 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma Core needle biopsy
Item
2. newly diagnosed core-biopsy proven breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
Breast Mammography | Calcification Suspicious magnification view mammogram
Item
3. has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any)
boolean
C0006141 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0006660 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C3862899 (UMLS CUI [2,3])
Examination of breast Clinical
Item
4. recent clinical breast examination (within prior 3 months)
boolean
C0199850 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
work up Mammary Ultrasonography | Mammography | clinical findings
Item
5. has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings
boolean
C0750430 (UMLS CUI [1,1])
C0080264 (UMLS CUI [1,2])
C0024671 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
Percutaneous needle biopsy Findings Suspicious Relevant | Mammography | Physical Examination | Ultrasonography
Item
6. has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound
boolean
C0558528 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C2347946 (UMLS CUI [1,4])
C0024671 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
work up | Indication Breast-Conserving Surgery
Item
7. after full diagnostic workup, participant is likely to be a candidate for breast conserving surgery.
boolean
C0750430 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
Medical contraindication Magnetic resonance imaging of breast
Item
8. no contraindications to breast mri:
boolean
C1301624 (UMLS CUI [1,1])
C0344104 (UMLS CUI [1,2])
Artificial cardiac pacemaker | Aneurysm clip | Implants Magnetic metal
Item
no pacemaker, aneurysm clip, or other implanted magnetic or ferromagnetic device;
boolean
C0030163 (UMLS CUI [1])
C0179977 (UMLS CUI [2])
C0021102 (UMLS CUI [3,1])
C0439876 (UMLS CUI [3,2])
Claustrophobia Controlled by Pharmaceutical Preparations | Valium | Ativan | Sedatives
Item
no claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative under her physician's orders;
boolean
C0008909 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0699187 (UMLS CUI [2])
C0699194 (UMLS CUI [3])
C0036557 (UMLS CUI [4])
venous access
Item
has intravenous access;
boolean
C0750164 (UMLS CUI [1])
Body Weight
Item
weight < 300 lbs;
boolean
C0005910 (UMLS CUI [1])
Magnetic Resonance Imaging Scanner Positioning Ability
Item
physically able to tolerate positioning in the mri scanner.
boolean
C0024485 (UMLS CUI [1,1])
C0183115 (UMLS CUI [1,2])
C1561964 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
follow-up Magnetic Resonance Imaging | follow-up Positron Emission Mammography | Vacuum-Assisted Biopsy Magnetic resonance imaging guidance | Ultrasound guided biopsy | Positron Emission Mammography Guidance for biopsy
Item
9. agrees to undergo follow-up mri or pem at 6 months and/or mri-guided vacuum-assisted biopsy, us-guided core biopsy, or pem-guided biopsy if needed based on results of the mri or pem examination
boolean
C1522577 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1522577 (UMLS CUI [2,1])
C3897879 (UMLS CUI [2,2])
C1710607 (UMLS CUI [3,1])
C0442974 (UMLS CUI [3,2])
C0456900 (UMLS CUI [4])
C3897879 (UMLS CUI [5,1])
C0883092 (UMLS CUI [5,2])
Informed Consent
Item
10. has signed study-specific consent form
boolean
C0021430 (UMLS CUI [1])
Contrast-enhanced Magnetic Resonance Imaging | Positron Emission Mammography Scan
Item
11. subject agrees to undergo a contrast-enhanced mri and pem scan within five business days of each other, prior to surgery.
boolean
C1707501 (UMLS CUI [1])
C3897879 (UMLS CUI [2,1])
C0441633 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Gender
Item
1. male
boolean
C0079399 (UMLS CUI [1])
Pregnancy
Item
2. pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding | Breast Feeding Discontinued
Item
3. active lactation or discontinued breastfeeding < 2 months prior
boolean
C0006147 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Age
Item
4. age less than 25 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
5. inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Therapeutic radiology procedure Breasts Affected
Item
6. prior radiation treatment to the affected breast(s)
boolean
C1522449 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Sentinel Lymph Node Biopsy Technetium 99m
Item
7. participant is scheduled for sentinel node procedure using radioactive tc-99m within 24 hours after the scheduled pem flex study
boolean
C0796693 (UMLS CUI [1,1])
C0303611 (UMLS CUI [1,2])
Gender Planning Prophylactic mastectomy
Item
8. women planning prophylactic mastectomy without histologic confirmation
boolean
C0079399 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C2191320 (UMLS CUI [1,3])
Neoadjuvant Chemotherapy | Operative Surgical Procedures | Chemoprevention Contralateral breast cancer | Tamoxifen | Arimidex | Aromatase Inhibitors
Item
9. individuals who are electing to undergo neoadjuvant chemotherapy prior to surgery (note: patients with prior contralateral breast cancer receiving chemoprevention with tamoxifen, arimidex, or other aromatase inhibitor are eligible)
boolean
C0600558 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0282515 (UMLS CUI [3,1])
C1096616 (UMLS CUI [3,2])
C0039286 (UMLS CUI [4])
C0878174 (UMLS CUI [5])
C0593802 (UMLS CUI [6])
Operative Surgical Procedure Breast
Item
10. 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])
Breast implant Breast
Item
11. breast implant(s) in any study breast(s)
boolean
C0920135 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Gender Neoplasm Metastasis Distant
Item
12. women who have had distant metastatic disease either currently or in the past
boolean
C0079399 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0443203 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
13. 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
14. 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])
Contrast-enhanced Magnetic Resonance Imaging Breast | Positron Emission Mammography
Item
15. has not had contrast-enhanced breast mri or pem within the past 12 months prior to study enrollment
boolean
C1707501 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C3897879 (UMLS CUI [2])
Study Subject Participation Status | Breast Imaging
Item
16. subject is currently enrolled in another breast imaging research study
boolean
C2348568 (UMLS CUI [1])
C0006141 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
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