Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions
Launched by HEIDELBERG UNIVERSITY · Dec 18, 2015
Trial Information
Current as of April 28, 2025
Completed
Keywords
ClinConnect Summary
Elastography is a method of imaging tissue stiffness. It is based on shear wave velocity information that can be mapped to create an image of the stiffness in the region of interest.
Sonoelastography is used to differentiate benign from malignant lesions since malignant lesions alter tissue elasticity.
Adding Shear Wave elastographic features to BI-RADS® feature analysis- especially in lesions scored BI-RADS® 3 and 4a- improved specificity of breast US mass assessment without loss of sensitivity.
The BI-RADS® categories are defined by the risk for a malignant lesion varying from benign B...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female
- • Age ≥18 years
- • Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound
- • Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine
- • Signed informed consent of study participation
- Exclusion Criteria:
- • Pregnant or lactating women
- • Women with breast implants on the same side as the lesion
- • Women that underwent local radiation or chemotherapy within the last 12 months
- • Women with history of breast cancer or breast surgery in the same quadrant
- • Lesions in or close to scar tissue (\< 1cm)
- • Skin lesions or lesions that have been biopsied previously
- • Lesion larger than 4 cm in the longest dimension
- • No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.
About Heidelberg University
Heidelberg University, a prestigious institution located in Germany, is renowned for its commitment to advancing medical research and clinical innovation. With a strong emphasis on interdisciplinary collaboration, the university fosters a dynamic environment for conducting clinical trials that aim to enhance patient care and improve health outcomes. Leveraging cutting-edge technology and a robust network of healthcare professionals, Heidelberg University is dedicated to exploring novel therapeutic approaches and contributing to the global medical community through rigorous scientific inquiry and ethical research practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heidelberg, , Germany
Youngstown, Ohio, United States
Bielefeld, , Germany
München, , Germany
Tubingen, , Germany
Villejuif, , France
Greifswald, , Germany
Marburg, , Germany
Kagoshima, Matsubaracho, Kagoshima Shi, Japan
'S Hertogenbosch, , Netherlands
Coimbra, , Portugal
Patients applied
Trial Officials
Michael Golatta, PD Dr. med., MHBA
Principal Investigator
University of Heidelberg, Department of Gynecology, Breast Unit
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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