To evaluate the efficacy of ROLL versus WGL in breast conserving surgery for non-palpable breast cancer.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The percentage of tumour-free margins (invasive and in situ) after the ROLL
vs. the WGL procedure (i.e. oncologic outcome).
2) The volume and maximum diameter of the lumpectomy of ROLL vs. WGL (i.e.
cosmetic outcome).
Secondary outcome
1) The cost-effectiveness of ROLL vs. WGL (i.e. operation time, radiological
localisation time, hospital stay and materials).
2) The degree of difficulty of the radiological and surgical procedure.
3) The degree of patient (dis)comfort of the radiological procedure ROLL vs.
WGL (number of procedures, pain, complications).
4) The success rate of the sentinel node procedure (visualisation and
localisation).
Background summary
Approximately 25% of breast cancers detected are non palpable. Accordingly, a
localization technique is required to help the surgeon to find and remove the
cancer. The current technique (wire guided localization) is difficult to
perform and has a high rate of tumour positive margins in the resected
specimen, requiring a second operation. A new approach in the localization and
resection of non-palpable malignant breast lesions is *radioguided occult
lesion localization* (ROLL).
Study objective
To evaluate the efficacy of ROLL versus WGL in breast conserving surgery for
non-palpable breast cancer.
Study design
A multicenter, prospective randomized controlled trial. Eligible patients will
be randomized for either radioguided occult lesion localization (ROLL) or
wireguided localization (WGL).
Intervention
Wire Guided Localisation technique
Patients in the WGL group will undergo intratumoural injection of a nuclear
radiotracer under stereotactic or ultrasound guidance, after injection a
scintigraphic imaging is made to monitor the migration of the radiotracer.
Afterwards a guide wire is inserted, again under stereotactic or ultrasound
guidance23. The excision of the primary tumour is guided by the inserted wire
and the sentinel node procedure is performed using preoperatively injected
patent blue and a gamma probe.
ROLL technique
Patients in the ROLL group will undergo intratumoural injection of the
radiotracer under stereotactic or ultrasound guidance. After scintigraphic
imaging, the excision of the primary tumour and the sentinel node procedure are
both guided by a gamma probe.
After localization the surgical excision is guided by the probe at its lowest
sensitivity setting.
Study burden and risks
There is no extra burden pre-, per-, and post operative. The radiofarmacon is
used standardly for the sentinel node procedure and is causing no damage to the
patient.
Heidelberglaan 100
3584 CX
NL
Heidelberglaan 100
3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with a non palpable breast carcinoma who are eligible for a lumpectomy and sentinel node biopsy
Exclusion criteria
- Pregnant or lactating patients
- Patients with a multi focal carcinoma
- Patients with ductal carcinoma in situ (DCIS) or a lobular carcinoma in situ (LCIS) without invasive growth
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 | NL15865.041.07 |