To assess the sensitivity and specificity of optical spectroscopy for the detection of Invasive Ductal Carcinoma (IDC) and Ductal Carcinoma In Situ (DCIS) deposits on resection margins during breast conserving surgery.
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this non-randomized controlled trial study we want to investigate the
accuracy of optical spectroscopy for the intra-operative detection of positive
resection margins during breast conserving surgery. The main endpoint of this
research will be the sensitivity and specificity of DRS for the detection of
measurement locations that are positive for IDC or DCIS according to
histopathologic evaluation.
Secondary outcome
We furthermore want to assess the usability of optical spectroscopy for
intra-operative guidance. For this secondary study parameter we intend to use
the System Usability Scale (SUS-score).
Background summary
Differences in optical characteristics between tumorous tissue and healthy
breast tissue allow for the discrimination between tissue types. By performing
optical measurements at the resection margin, a surgeon can potentially detect
positive resection margins during surgery. Detecting positive resection margins
intra-operatively allows changing the margin status during the surgery to evade
additional therapy with re-excision or boost-radiotherapy.
Previous ex vivo and in vivo research conducted in the NKI-AvL indicated that
optical spectroscopy has the potential to be used as an intraoperative margin
assessment tool for breast conserving surgery. Optical parameters such as
absorption and scattering by the tissue, but predominantly the F/W-ratio
provided excellent discrimination between normal tissue and invasive breast
carcinoma. To evaluate the true potential of optical spectroscopy as an
intra-operative tool, measurements are now being performed during surgery at
the resection margin.
Study objective
To assess the sensitivity and specificity of optical spectroscopy for the
detection of Invasive Ductal Carcinoma (IDC) and Ductal Carcinoma In Situ
(DCIS) deposits on resection margins during breast conserving surgery.
Study design
Non-randomised controlled trial
Study burden and risks
The study population for this study will consist of patients that receive
surgical treatment for IDC or DCIS. Participation in this study will not
involve additional hospital visits, physical examinations or tests, or the
completion of questionnaires or diaries for the patient. The patient can give
informed consent during one of the visits to the outpatient clinic.
Measurements will involve the patient*s exposure to harmless light, and in some
cases, a small biopsy (~0.1 cm3) being taken in tissue that will be removed
surgically. The process of measuring will add no more than 15 minutes to the
total operation time, during which patients will be under general anaesthesia.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Women undergoing breast conserving surgery, with or without previous treatment
with neo-adjuvant chemotherapy
Exclusion criteria
Suspected oversensitivity to light; e.g. patient who has had photodynamic
therapy
Design
Recruitment
Medical products/devices used
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 | NL69986.031.19 |