To assess the influence of sentinel-node biopsy (SNB) on visualization of regional LNs using newly developed MRI techniques.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the number of regional LNs detected in
pre-sentinel-node biopsy (SNB) and post-SNB MRI scans, taking into account the
number of LNs excised during SNB.
Secondary outcome
The secondary study parameter is the number of LNs visible on the standard CT
scan that is used for RT planning, in comparison with the pre-SNB and post-SNB
MRI scans. Another study parameter is the number of patients who are able to
cope with the scanning procedure; this is monitored for all participants. The
coping ability for scanning (pre-SNB and post-SNB) determines continuation of
the study or the need for adaptation of the scanning protocol.
Background summary
The standard treatment for breast cancer patients with tumour-positive sentinel
node(s) is axillary lymph node dissection (ALND). Based on recent clinical
studies (AMAROS and Z0011), ALND is increasingly being omitted, or instead
replaced by regional radiotherapy (RT). In current RT planning, the lymph node
(LN) areas are delineated indirectly on computed topography (CT) scans by
anatomical boundaries, since individual LNs are usually not visible on CT.
Consequently, target volumes in regional RT are relatively large, resulting in
large high-dose volumes in organs-at-risk (OARs; lungs, heart, brachial
plexus). RT-induced morbidity is 10-20%; in order to reduce this rate, more
accurate targeting of the LNs is desired. In contrast to CT, magnetic resonance
imaging (MRI) allows for direct imaging of the LNs and surrounding anatomy, due
to its superior soft-tissue contrast. Using MRI may facilitate delineation of
the individual LNs and the surrounding OARs. This can result in smaller treated
volumes, potentially leading to less toxicity. We have developed MRI
techniques, in healthy volunteers, to visualize individual LNs. Before
considering the addition of MRI to RT planning, or the development of
MRI-guided RT techniques of the LNs, it is necessary to test the scanning
protocol in patients. This is required since the patient*s anatomy is affected
by the sentinel-node biopsy (SNB), which is performed during breast-conserving
surgery (BCS) or mastectomy. Therefore, it is important to study the effects of
SNB on the visualization of LNs using the new MRI techniques. Moreover, the
endurance of patients, after BCS or mastectomy, can differ from healthy
volunteers.
Study objective
To assess the influence of sentinel-node biopsy (SNB) on visualization of
regional LNs using newly developed MRI techniques.
Study design
In this observational study, first, an MRI scanning protocol is optimized in
cT1-3N0 and/or cTisN0 patients. Then, the optimized protocol is applied in
cT1-3N0 and/or cTisN0 patients who are to be scanned both before and after
sentinel-node biopsy (SNB). Coping ability of all patients is monitored.
Influence of SNB on MRI is evaluated by checking consistency of the number of
regional LNs detected in pre-SNB and post-SNB MRI scans, which are aimed to be
performed on the same day as routine consultations.
Study burden and risks
No benefits are expected for the patients and their treatments will not be
affected.
No risks are known for patients undergoing MRI when they are screened according
to the MRI safety criteria. No contrast agent will be applied. Two MRI scans
will be acquired for each participant: one before sentinel-node biopsy (SNB),
and one after SNB. From the patients* perspective, additional time required is
limited to 30 minutes per MRI session, including scanning, patient preparation,
changing of clothes etc. The scan sessions are scheduled on the same day as the
corresponding routine consultations for the RT planning procedure. Participants
will lie in RT treatment position, i.e. supine with both arms in abduction,
resting in an arm support. The ability to hold one*s arms in abduction during
scanning is not expected to be a problem, although it can be affected after
surgery. Therefore, coping ability is monitored for all patients. The study can
lead to insights about the possible added value of using MRI techniques in
regional RT planning for breast-cancer and/or DCIS patients in the future.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Female gender; >18 years old; breast-cancer patient or DCIS patient; if breast-cancer: stage T1-3 tumour, i.e. tumour of any size without direct extension to the skin; no pathologically enlarged lymph node(s) at clinical inspection (cN0), i.e. ultrasound and/or fine-needle aspiration; scheduled for sentinel-node biopsy; has given written informed consent
Exclusion criteria
Legal incapability; previous surgery of axillary and/or supraclavicular region; previous neo-adjuvant systemic treatment; adjuvant systemic therapy prior to radiotherapy course; immediate reconstruction of the breast after mastectomy; previously known inability to maintain the scanning position (supine with arms in abduction) for 30 minutes; MRI exclusion criteria of the MRI safety group of Radiology (UMC Utrecht); not meeting the inclusion criteria
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 | NL50046.041.14 |