Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient

Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis

Injection of contrast enhancing agent Gadovist for MRI investigation

Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis

Injection of contrast enhancing agent Imeron for B-CT investigation

Sabine Ohlmeyer, Dr. med

Arnoud Meijer, MD

Martin Wasser, MD

Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems

The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging.

The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.

The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.

Comparison between both modalities in single patients

Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics

The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis.

Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.

The secondary objective is to collect data for comfort of CE-BCT and CE-MRI using a patient questionnaire of closed questions. The questionnaire asks in 7 categories for 1. Overall rating of the examination 2. Comfort of the device during examination 3. The feel of the operating noise of the device 4. The rating of the space provided by the device 5. The duration of the examination 6. The question if the patient would agree to have the examination again, if necessary with the device 7. After both modalities which diagnostic method would be the preference, MRI or BCT. Every question can be rated with 5 possible ratings from very good to very bad or adapted possibilities like pleasantly quit to unpleasantly loud.

CRO Dr. med. Kottmann GmbH

RQM+ (Germany) GmbH

AB-CT - Advanced Breast-CT GmbH

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Syndrome

Obesity

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

This is a cross-sectional clinical study to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. There is no intervention.

Breast CT

Sherry Chow, PhD

The overall objective of this clinical study is to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. These evaluations will help support follow-up clinical research utilizing breast density acquired by breast CT as a surrogate endpoint biomarker to evaluate breast cancer preventive strategies. The long-term goal of these research efforts is to develop safe and effective preventive strategies to reduce obesity-associated breast cancer burden in our catchment area.

Overweight/obese Mexican-origin women in Southern Arizona.

Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona

To determine the feasibility of applying a novel clinical prototype of breast CT to assess breast density on non-compressed breasts. Feasibility will be evaluated by the proportion of unmeasurable breast density within our study population utilizing computerized tomography (CT) scan.

To determine the association between metabolic syndrome and breast CT-derived density measures through comparison of CT-derived breast density measures between women with or without metabolic syndrome, characterized by having at least three components among abdominal obesity, high serum triglycerides, low high-density lipoprotein cholesterol, high serum glucose, and high blood pressure.

To compare the CT-derived breast density measures versus the individual components of metabolic syndrome to reveal associations between breast density and specific metabolic characteristics.

University of Arizona

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

About 187 subjects, who had diagnostic imaging of the breast including mammography and were categorized as Breast Imaging-Reporting and Data System(BIRADS) scores 1, 2, 3, 4, or 5, received KBCT imaging without contrast injection.

About 231 subjects, who had diagnostic imaging of the breast including mammography and were scheduled for biopsy or surgery, received contrast-enhanced KBCT imaging of the affected breast before biopsy or surgery.

Contrast-enhanced KBCT includes pre-contrast KBCT scan and post-contrast KBCT scan. After the pre contrast scan is completed, a bolus injection of a low osmolar, nonionic, iodinated 300mg of iodine per mL contrast agent, will be injected at a rate of approximately 2.0 mL/s, for a total injection time of approximately 30-60 seconds. 30-60 seconds after the contrast injection, the post-contrast scan will be acquired.

Contrast-enhanced KBCT

Zhaoxiang Ye, MD, PhD

Peihong Wu, MD

This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic accuracy of breast cancer.

Koning Breast CT for Breast Imaging in China

Efficacy of KBCT, CE-KBCT and Mammography will be assessed based on the sensitivity for detecting breast cancer and the specificity for correctly categorizing non-cancer.

All enrolled and scanned patients will be included in the safety analysis. Anticipated and unanticipated adverse events will be tabulated according to severity and relation to device.

Koning (Tianjin) Medical Equipment Co., Ltd

The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.

Koning Breast CT-guided Biopsy

The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.

Koning Breast Computed Tomography Guided Biopsy

Koning Breast CT-guided Biopsy Phase I Trial

The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.

Elizabeth Wende Breast Care, LLC

Koning Corporation

Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.

Koning Breast CT

The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.

Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial

Tumor volume will be measured with KBCT imaging at the beginning of the therapy (baseline), mid-point of the therapy (about 3 months after the treatment starts) and end of therapy (about 4-6 months after the treatment starts). The volume change from the baseline during the treatment will be recorded.

Adverse Events will be recorded as a measure of safety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics	NCT05989022	Breast Cancer D...	Injection of co... Injection of co...	18 Years -	AB-CT - Advanced Breast-CT GmbH
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona	NCT04799665	Metabolic Syndr... Obesity Associa...	Breast CT	40 Years - 65 Years	University of Arizona
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics	NCT05989022	Breast Cancer D...	Injection of co... Injection of co...	18 Years -	AB-CT - Advanced Breast-CT GmbH
Koning Breast CT for Breast Imaging in China	NCT01792999	Breast Cancer	Contrast-enhanc...	35 Years -	Koning (Tianjin) Medical Equipment Co., Ltd
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics	NCT05989022	Breast Cancer D...	Injection of co... Injection of co...	18 Years -	AB-CT - Advanced Breast-CT GmbH
Koning Breast Computed Tomography Guided Biopsy	NCT01750320	Breast Cancer	Koning Breast C...	35 Years -	Koning Corporation
Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring	NCT01771497	Breast Cancer	Koning Breast C...	18 Years -	Koning Corporation
Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring	NCT01771497	Breast Cancer	Koning Breast C...	18 Years -	Koning Corporation

Spots Global Cancer Trial Database for breast ct

Every month we try and update this database with for breast ct cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for breast ct

Every month we try and update this database with for breast ct cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for breast ct cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.