Eligibility Breast Cancer NCT00484614

1 Formulários

StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT00484614

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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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Eligibility Breast Cancer NCT00484614