Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients will undergo a native high-resolution and a dynamic contrast-enhanced CT, both sides respectively.

Native and dynamic contrast-enhanced CT

Verena Deserno, Dipl.-Biol., M.A.

Christiane Kuhl, Univ.-Prof. Dr. med.

The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Even though the implementation of the digital mammography combined with the mandatory screening-programs lead to significant improvements, sensitivity and specificity of these examinations need to be clearly classified as improvable. Generally, it is stated that the necessary transit from 2-D projected images to 3-D tomography will be crucially advantageous as magnetic resonance imaging has already shown. Similar or even major advantages can be expected by new approaches regarding CT with very high local resolution, better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening. A device that meets these demands and is also applicable for dynamic scans after intravenous administration of a contrast agent, has been developed with the support by the European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF). Publications on technical and experimental results are already available. An evaluation in the clinical use is missing yet. The primary aim of this study is to evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of the breast.

Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT

By using the images diagnostic criteria for identification and characterization of the pathologic and physiologic changes of the female breast will be elaborated.

Detection mode means the prospective visibility of a carcinoma in one or more independent imaging methods, respectively.

Biological value will be calculated by amount of high and intermediate grade vs. low grade lesions, status of Ki-67 values, distribution of luminal a, luminal b, Her2/neu and basal, distribution of receptor status

RWTH Aachen University

Digestive System Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Soft Tissue Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Mona-Elisabeth Revheim, MD

Therese Seierstad, PhD

Øyvind S Bruland, Prof., MD

Knut Håkon Hole, MD

Lars Julsrud, MD

The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.

Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI

Oslo University Hospital

Nuclear Medicine Phycisian

Respiratory Tract (Lung and Bronchial) Diseases

Liver Neoplasms

Pulmonary Atelectasis

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Anesthetics

Liver Extracts

Computed tomography scans are performed every 15 minute during the first 45 minutes during general anaesthesia using high frequency jet ventilation.

On High frequency jet ventilation, Every 15 minutes, after induction of general anaesthesia, a computed tomography of the lower part of the lungs are taken (10 cm volume, with the top of the right diaphragm as the lower border)

HFJV

Atelectasis formation using HFJV during stereotactic solid organ ablations.

Primary endpoint will be to study the formation of atelectasis during HFJV. Secondary endpoint will be to study liver displacement over time. Reference groups will be found in previous published articles as referred to above.

Materials and methods: A radiological protocol has been made for the CT-scanner to take 10 cm volume Scans of the lower part of the lung. The scans will have its' lower border tangential to the top of the diaphragm. The first scan will be performed in the same session as the routine scan of the liver is performed after the patient is anesthetized. These Scans will then be repeated every 15 minute during the first 45 minutes. Arterial bloodgas analysis, transcutaneous CO2, blood pressure, saturation as well as parameters from the jet ventilator and the standard ventilator will be recorded.

The use of HFJV in abdominal surgery as well as in out-of-operating theatre environment, is not well studied. In percutaneous liver thermal ablation the patient is anesthetized and intubated on the CT-bed where the liver ablation procedure is performed. Atelectasis is formed as soon as the patient is supine. Anesthesia itself also contributes to this. In extreme cases almost half the lung can be collapsed during anaesthesia, before any surgery has taken place.

The investigators have noticed that during this specific surgery, dynamic lung compliance does not necessarily worsen during HFJV but rather being unchanged or in some cases even becoming better and want to study this further and investigate the formation of atelectasis during HFJV. There are studies where atelectasis has been measured in a similar way as in this planned study, that is, with thin axial CT-scans at representative levels of the lung. This is during conventional lung ventilation, and has not yet been studied during HFJV.

Inclusion criteria: A total of n= 25 patients planned for elective liver tumor thermal ablation will be recruited after written informed consent.

Exclusion criteria: Patients 1/ under the age of 50 years, 2/with severe, poorly controlled lung disease.

The lung images will be saved in DICOM format and the tissue density will be analysed quantitatively. For each scan, the inner contour of each hemithorax will be manually drawn, excluding the chest wall, mediastinum, pleural effusions, and regions representing partial volume effects. Liver displacement can be measured from the routine CT-scans taken before and after the procedure.

Statistical methods: Chi2-analysis will be used to calculate the percentage of atelectasis in the lung.

Power calculation: Since the rate of atelectasis formation in the study groups is not known, it is impossible to perform power calculation for this trial. This study may clarify this issue in the planning of further studies.

This study may contribute to more knowledge about HFJV and its' effect on lung physiology, it may also contribute as a generator of new hypothesis and it might be a follow up study where the effect of alveolar recruitment maneuver (ARM) is studied.

Atelectasis Formation Using HFJV During Stereotactic Solid Organ Ablations

Atelectasis Formation Using High Frequency Jet Ventilation During Stereotactic Solid Organ Ablations

Computed tomography Scans will be taken during general anaesthesia at the start of jet ventilation, t=0, and then at t=15 minutes, t=30 minutes and t=45 minutes. A total number of four scans will be performed in each study subject.

Routine CT Scans taken during surgery will be studied to calculate liver displacement over time.

Karolinska Institutet

Senior Consultant, Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT	NCT02798562	BI-RADS 4 BI-RADS 5 BI-RADS 6 High Risk of Br...	Native and dyna...	40 Years -	RWTH Aachen University
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients	NCT01276483	Soft Tissue Neo... Gastrointestina...		-	Oslo University Hospital
Atelectasis Formation Using HFJV During Stereotactic Solid Organ Ablations	NCT03378752	High Frequency ... Atelectasis	HFJV	50 Years -	Karolinska Institutet

Spots Global Cancer Trial Database for computer tomography