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Trial Title:
Study on Female Patients' Mammographic Texture Features
NCT ID:
NCT06469606
Condition:
Breast Cancer
Artificial Intelligence
Mammography
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
AI tool
Description:
Both the arms will undergo the use of "AI tool" developed in the group. The tool will be
trained to detect outcomes.
Arm group label:
Participant diagnosed with breast cancer
Arm group label:
Participant not diagnosed with breast cancer
Summary:
Mammography is the most common method for breast imaging, and it provides information for
model building and analysis. Radiomics applied to mammography has the potential to
revolutionize clinical decision-making by providing valuable insights into risk
assessment and disease detection. Despite this, the influence of imaging parameters and
clinical and biological factors on radiological texture features remains poorly
understood. There is a pressing need to overcome the obstacle of system-inherent effects
on mammographic images to facilitate the translation of radiological texture features
into routine clinical practice by enabling reliable and robust AI-based or AI-aided
decision-making. Furthermore, understanding the relationship between imaging parameters,
textural features, and clinical and biological information supports the clinical use of
AI. The objective of this study is to evaluate AI methods for clinical practice and to
study how it relates to clinical factors and biological features.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Candidate is a biological female aged 18 years or above;
- Candidate is willing and able to give informed consent and gives their written
consent for the participation in the study;
- There is a clinical indication for a uni- or bilateral mastectomy
Exclusion Criteria:
- Candidate lacks the capacity to provide informed consent;
- Candidate has breast implants
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 17, 2024
Completion date:
December 15, 2038
Lead sponsor:
Agency:
Tampere University Hospital
Agency class:
Other
Collaborator:
Agency:
Tampere University
Agency class:
Other
Collaborator:
Agency:
Kuopio University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Eastern Finland
Agency class:
Other
Collaborator:
Agency:
University of Turku
Agency class:
Other
Collaborator:
Agency:
University of Oulu
Agency class:
Other
Source:
Tampere University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06469606
