ID

19616

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00484614

Stichworte

Versionen (1)
  1. 16.01.17 16.01.17 -
Hochgeladen am

16. Januar 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT00484614

Englisch

Eligibility Breast Cancer NCT00484614

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gender | Age

Datentyp

boolean

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

Breast Carcinoma Core needle biopsy

Datentyp

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)
Beschreibung

Breast Mammography | Calcification Suspicious magnification view mammogram

Datentyp

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)
Beschreibung

Examination of breast Clinical

Datentyp

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
Beschreibung

work up Mammary Ultrasonography | Mammography | clinical findings

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

work up | Indication Breast-Conserving Surgery

Datentyp

boolean

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

Medical contraindication Magnetic resonance imaging of breast

Datentyp

boolean

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

Artificial cardiac pacemaker | Aneurysm clip | Implants Magnetic metal

Datentyp

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;
Beschreibung

Claustrophobia Controlled by Pharmaceutical Preparations | Valium | Ativan | Sedatives

Datentyp

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;
Beschreibung

venous access

Datentyp

boolean

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

Body Weight

Datentyp

boolean

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

Magnetic Resonance Imaging Scanner Positioning Ability

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Informed Consent

Datentyp

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.
Beschreibung

Contrast-enhanced Magnetic Resonance Imaging | Positron Emission Mammography Scan

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. male
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
2. pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

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

Breast Feeding | Breast Feeding Discontinued

Datentyp

boolean

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

Age

Datentyp

boolean

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

Informed Consent Unable

Datentyp

boolean

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

Therapeutic radiology procedure Breasts Affected

Datentyp

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
Beschreibung

Sentinel Lymph Node Biopsy Technetium 99m

Datentyp

boolean

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

Gender Planning Prophylactic mastectomy

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Operative Surgical Procedure Breast

Datentyp

boolean

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

Breast implant Breast

Datentyp

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
Beschreibung

Gender Neoplasm Metastasis Distant

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Blood glucose measurement | Positron Emission Mammography

Datentyp

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
Beschreibung

Contrast-enhanced Magnetic Resonance Imaging Breast | Positron Emission Mammography

Datentyp

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
Beschreibung

Study Subject Participation Status | Breast Imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0006141
UMLS CUI [2,2]
C0079595
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00484614

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video