HumRes66608
|
SNCTP000006333
|
BASEC2024-D0101
Use of the Histolog Scanner Confocal Microscope in Routine Conservative Breast Cancer Surgery
Summary description of the study
Our research project aims to determine whether the Histolog Scanner (a confocal microscope allowing macro and microscopic analysis) can reduce the number of patients who need to undergo a second surgery due to non-healthy margins (incomplete resection)
(BASEC)
Intervention under investigation
Use of the Histolog Scanner to visualize a breast lumpectomy
(BASEC)
Disease under investigation
Breast cancer
(BASEC)
Criteria for participation in trial
Female subjects ≥18 years old Subjects undergoing conservative breast surgery for invasive and/or in situ ductal or lobular carcinoma. Subjects capable of reading, understanding, and voluntarily signing the informed consent The subject speaks French (BASEC)
Exclusion criteria
The subject will undergo a planned mastectomy or breast reduction The subject is pregnant or breastfeeding The subject is participating in another clinical study that could affect the results (BASEC)
Female subjects ≥18 years old Subjects undergoing conservative breast surgery for invasive and/or in situ ductal or lobular carcinoma. Subjects capable of reading, understanding, and voluntarily signing the informed consent The subject speaks French (BASEC)
Exclusion criteria
The subject will undergo a planned mastectomy or breast reduction The subject is pregnant or breastfeeding The subject is participating in another clinical study that could affect the results (BASEC)
Trial sites
Freiburg
(BASEC)
not available
Sponsor
HFR & SamanTree Grant
(BASEC)
Contact
Contact Person Switzerland
Dr Benedetta Guani
+41 26 306 29 26
benedetta.guani@clutterh-fr.chHFR Fribourg – Hôpital cantonal
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
21.03.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Confocal Histolog Scanner in routine Breast-Conserving Surgery (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available