Age
Item
1. subject is > 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma Size Ultrasonography | Breast Carcinoma Advanced Locally TNM Breast tumor staging
Item
2. histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (labc: t3-4nxmx or txn2-3mx)
boolean
C0858252 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0474926 (UMLS CUI [2,4])
HER2-positive carcinoma of breast First Relapse
Item
3. her2-positiv breast cancer first recurrence
boolean
C1960398 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
HER2-positive carcinoma of breast primary metastatic
Item
4. her2-positiv breast cancer primary metastatic
boolean
C1960398 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
Primary tumor HER2 Positive HercepTest | Primary tumor HER2 Positive FISH
Item
5. her2 status has been determined on biopsy material from the primary tumour and found to be her2-positive, defined as a dako herceptest™ score of 3+ or else 2+ and fish positive
boolean
C0677930 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1512416 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
FDG-Positron Emission Tomography and Computed Tomography Scan
Item
6. [18f]fdg pet/cect performed within 7 days before administration of imp
boolean
C4521453 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status of =< 2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
8. hematological, liver and renal function test results within the following limits:
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
White Blood Cell Count procedure
Item
white blood cell count: > 2.0 x 10^9/l
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin: > 5.0 mmol/l
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelets: > 50.0 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
alt, alp: =< 3 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin =< 2.0 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Serum creatinine normal
Item
serum creatinine: within normal limits
boolean
C0438244 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
9. a negative pregnancy test (serum beta-hcg) at screening for all subjects of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Capability Receive Diagnostic procedure
Item
10. subject is capable to undergo the diagnostic investigations to be performed in the study
boolean
C2698977 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
Informed Consent
Item
11. informed consent
boolean
C0021430 (UMLS CUI [1])
Hypersensitivity Dotarem | Autoimmune Disease | Communicable Disease Serious | HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic | Investigational New Drugs
Item
1. known hypersensitivity to dotarem® 2. active known autoimmune disease or history of autoimmune disease 3. active serious infection according to investigator evaluation 4. known hiv positive or chronically active hepatitis b or c 5. administration of other investigational medicinal product within 30 days of screening
boolean
C0020517 (UMLS CUI [1,1])
C0114857 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0019699 (UMLS CUI [4])
C0524909 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
C0013230 (UMLS CUI [7])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Contraceptive methods Except Hormonal contraception | Cancer Other Primary | Brain Tumor, Primary | Exception Carcinoma in situ of uterine cervix Treated | Exception Squamous cell carcinoma of skin Treated | Exception Basal cell carcinoma Limited Controlled | Signs Disease Other | Signs Metabolic Diseases | Signs Mental disorders | Disease Investigational New Drugs Contraindicated | Condition Investigational New Drugs Contraindicated | Disease Influence Protocol Compliance | Condition Influence Protocol Compliance | Disease At risk Complications | Condition At risk Complications
Item
6. pregnant or breast-feeding 7. women capable of childbearing not using a sufficient non-hormonal method of birth control 8. other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the imp, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0700589 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C2985296 (UMLS CUI [4,3])
C1707251 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0750974 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0851140 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0553723 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0007117 (UMLS CUI [9,2])
C0439801 (UMLS CUI [9,3])
C2911690 (UMLS CUI [9,4])
C0311392 (UMLS CUI [10,1])
C0012634 (UMLS CUI [10,2])
C0205394 (UMLS CUI [10,3])
C0311392 (UMLS CUI [11,1])
C0025517 (UMLS CUI [11,2])
C0311392 (UMLS CUI [12,1])
C0004936 (UMLS CUI [12,2])
C0012634 (UMLS CUI [13,1])
C0013230 (UMLS CUI [13,2])
C1444657 (UMLS CUI [13,3])
C0348080 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C1444657 (UMLS CUI [14,3])
C0012634 (UMLS CUI [15,1])
C4054723 (UMLS CUI [15,2])
C0525058 (UMLS CUI [15,3])
C0348080 (UMLS CUI [16,1])
C4054723 (UMLS CUI [16,2])
C0525058 (UMLS CUI [16,3])
C0012634 (UMLS CUI [17,1])
C1444641 (UMLS CUI [17,2])
C0009566 (UMLS CUI [17,3])
C0348080 (UMLS CUI [18,1])
C1444641 (UMLS CUI [18,2])
C0009566 (UMLS CUI [18,3])