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Imaging Diagnostics by Combining Contrast Agents

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Imaging Diagnostics by Combining Contrast Agents (19) TZZ Z _T (11) EP 2 907 526 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 19.08.2015 Bulletin 2015/34 A61K 49/04 (2006.01) A61K 51/04 (2006.01) A61K 49/06 (2006.01) (21) Application number: 15155866.5 (22) Date of filing: 20.06.2008 (84) Designated Contracting States: (72) Inventor: Wiebelitz, Ulrike AT BE BG CH CY CZ DE DK EE ES FI FR GB GR 13158 Berlin (DE) HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR (74) Representative: Kilger, Ute Boehmert & Boehmert (30) Priority: 22.06.2007 EP 07110922 Anwaltspartnerschaft mbB Patentanwälte Rechtsanwälte (62) Document number(s) of the earlier application(s) in Pettenkoferstrasse 20-22 accordance with Art. 76 EPC: 80336 München (DE) 12199299.4 / 2 572 735 12168380.9 / 2 514 442 Remarks: 08774183.1 / 2 170 405 This application was filed on 20-02-2015 as a divisional application to the application mentioned (71) Applicant: mivenion GmbH under INID code 62. 10115 Berlin (DE) (54) Imaging diagnostics by combining contrast agents (57) The present invention relates to the use of a combination of several contrast agents having different imaging properties with respect to imaging representation. EP 2 907 526 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 907 526 A1 2 Description from suspect lesions and to prepare and assess these samples histopathologically. [0001] The present invention relates to the use of a [0005] MRI examination of the female breast has very combination of several contrast agents having different high sensitivity in comparison to other imaging modali- imaging properties. 5 ties. Due to this modality, it is possible to detect different [0002] Chronic diseases are an important field of ap- forms of breast cancer at an early stage. A particular plication for imaging diagnostics. The two most frequent advantage of MRI is the fact that imaging examination is chronic diseases, cardiovascular diseases and tumour not complicated in a significant way by non-tumerous tis- diseases, alone account for the greater part of the 800 sue alterations, such as e.g. surgical cicatrices, tissue million imaging diagnoses which are carried out every 10 alterations by radiological treatment, prostheses or mas- year worldwide. The majority of examinations are ultra- topathically altered glandular tissue. Due to these char- sonic examinations, X-ray examinations, such as CT and acteristics, MRI has meanwhile found a large range of MRI examinations, but also nucleomedical and optical applications. methods are often used. For all of these examination [0006] The high sensitivity of MRI of the breast is, how- methods, contrast agents are clinically available. Con- 15 ever, associated with low specificity. Low specificity im- trast agents provide specific information determined by plies that almost all malignant tumours are detected but their pharmacokinetic and pharmacodynamic properties. that, at the same time, many foci which, in the course of However, imaging examination alone often allows only subsequent examinations, are found to be harmless, are for little diagnostic information. Due to this reason, it is represented as malignant tumours. The reason for this often necessary to carry out various examinations with 20 is that MRI uses contrast agents which improve the meth- the same modality and different contrast agents or to od to a degree that allows to show even minor irregular- carry out different examinations with different modalities, ities in the breast tissue to be examined. These contrast in order to allow a reliable diagnosis. This procedure in- agents are not appropriate to make a satisfactory distinc- volves high costs and strain/stress for the patient. Fur- tion between benign and malignant lesions. As a conse- thermore, this approach is time-consuming and, the be- 25 quence of the diagnostic results, the physician has to ginning of a necessary therapy is often delayed due to initiate further examinations which are to assess the pre- the fact that several diagnostic examinations are re- sumptive diagnostic findings in greater detail. On the one quired. A further disadvantage is the assignment of di- hand, further imaging methods are applied, on the other agnostic signals from different imaging examinations. hand, it is possible to make an MRI-based biopsy of the Very often, it is not possible to correlate suspect lesions 30 suspect tissue and establish an exact diagnosis by his- of one examination to the lesions detected in another tological examination. The fact that this is a method of examination, which considerably complicates the diag- high technical standard involving high costs is one of the nosis for the physician. The necessity to carry out differ- reasons why MRI imaging has not yet been established ent diagnostic examinations in order to establish a relia- as standard method for breast cancer diagnosis. As to ble diagnosis can be illustrated by the imaging diagnos- 35 clinical application of CT, the situation is similar. CT also tics of tumours, particularly the imaging diagnostics of plays a major role in tumour diagnosis. For example, the breast cancer. CT-contrast agent Ultravist® is used for imaging CT di- [0003] Breast cancer is one of the most frequent tu- agnosis of liver tumours. This method also shows minor mours and the most frequent tumour disease with wom- specificity with respect to the contrast agents based di- en. Improved early diagnosis, such as screening mam- 40 agnosis. Thus, itis acentral task to improve the specificity mogram, and complex treatment protocols allowed a de- of diagnostic imaging in order to make it widely applica- crease in mortality over the last years. Nonetheless, a ble. great number of breast cancer cases are only detected [0007] One possibility to improve the specificity of in- at a late stage. Hence, the early diagnosis of tumours is formation provided by an imaging modality is to use im- a great challenge. This is particularly important as the 45 proved signal altering or signal modulating contrast growth of small tumours is limited to the organ so that agents. Today, contrast agents are clinically available for there is hope to remove the tumour completely and to most of the imaging methods. These contrast agents are conserve the organ if tumours are detected in early stag- selected in such a way that, on the one hand, their ap- es. Medical methods available up to present meet this plication is acceptable with humans and that, on the other requirement only inadequately. Hence, it is important to 50 hand, they can interact with the physical signal of the provide improved methods of early and reliable diagno- relevant examination modality in a very specific manner. sis. Most empirical data regarding the application of contrast [0004] Today, the physician can use various diagnostic agents relate to X-ray-based CT examination methods. methods with the imaging techniques playing a major Diagnostic radiology uses contrast agents which atten- role. Among the imaging techniques, ultrasonic diagno- 55 uate the X-rays. These are, amongst others, substances sis, CT, MRIand nucleomedical techniques, suchas PET with a great number of elements having high electron and SPECT, are the most relevant techniques. With un- density, such as iodine. These contrast agents can be cleardiagnostic findings, the aim is to take tissue samples applied in a variety of ways in humans, however, the most 2 3 EP 2 907 526 A1 4 frequent applications are applications in which the con- This phase can be followed by a rapid but often incom- trast agents are introduced by bolus injection into the plete washout phase. The signal in the lesions can be blood circulation. By applying contrast agents in this way, inferior to the signal in the surroundings, as, due to the it is possible to make the blood flow in a specific organ disturbed barrier function, the wash-out process in the visible for the duration of the examination. This applica- 5 lesion can occur faster than in the healthy tissue where tion form of contrast agents allows to obtain important the intact barrier reduces the velocity of back flow. Back information on the anatomy, morphology and function of flow is however always caused by fast decrease of the specific organs. Thus, it is possible to obtain information ECCM concentration in the blood. This is a characteristic on the condition of a blood vessel by detecting a contrast property of the ECCM used according to the invention. agent in this blood vessel and by visualizing the vessel 10 Fast elimination from blood circulation requires incom- lumen. Existing constrictions of the coronary arteries can plete and loose binding of plasma protein and is ensured be made visible by coronary angiography without diffi- by renal and/or hepatic elimination capacity, in contrast culties, thus, leading to the diagnosis of coronary steno- to ECCM, lesion-specific contrast agents (LSCM) used sis. Another parameter providing significant diagnostic according to the invention are characterised in that they data is the velocity with which the contrast agent applied 15 can interact with a specific target structure in the organ- flows into the organ. Thus, it is possible to draw conclu- ism or are altered by said specific structures in such a sions with respect to the blood circulation within a par- way that they can be visualised in an imaging technique ticular organ. as a consequence of the interaction or alteration. A fur- [0008] The application of contrast agents is as impor- ther property by which they can be distinguished from tant in MRI as it is in radiodiagnostics. For X-ray-based 20 ECCM is their longer retention in blood circulation. This examinations as well as for MRI examinations, a great property can be achieved, for example, by ensuring that number of different contrast agents is available to the the relevant LSCM are characterised by a stronger plas- physician.
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