This study will evaluate the significance of TISENO for early detection of mamma carcinomas and benign breast diseases.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The goal of the study is evaluation of the TISENO technique in early detection
of breastcancer and its role in detecion of benign lesions.
Secondary outcome
none
Background summary
In the Netherlands 12000 women with breastcancer are diagnosed. The chance of
having breastcancer lifetime is 12-13 %. Early detection is very important
despite the improvement of diagnostic techniques and therapeutic options.
Mammography and ultrasound are the conventional techniques in detection of
breastcancer. This can be difficult in younger women with more dense glandular
parenchyma. Therefore thermographic imaging can be useful in detecting
breastcancer in some women.
TISENO (Thermal Imaging in SENOlogy) is a device for thermographic digitalized
image reproduction using high-resolution liquid crystal plates for early
detection of breast laesions. Angiogenesis, i.e. the formation of new blood
vessels from a pre existent vascular system is a condition for tumors to grow
and metastasize. The temperature will increase with the formation of the tumor
and this can be thermal detected on the skin.
Study objective
This study will evaluate the significance of TISENO for early detection of
mamma carcinomas and benign breast diseases.
Study design
In this prospective clinical study all new female patients will be included
with an atypical mammography in population screening or with an abnormality on
palpation or other complaints.
The patients will be examined physically and will be send for TISENO after a
signed agreement (informed consent). The TISENO procedure will take about 5
minutes. Afterwards all patients will have a mammography and ultrasound or MRI.
These last techniques will be conclusive in the defintive diagnosis and
therapy.
Study burden and risks
none.
Kleiweg 500
3045PM Rotterdam
NL
Kleiweg 500
3045PM Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Women with a lesion of the breast (benign or malign)
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL32619.101.10 |