To develop and evaluate an adaptive MRI-only workflow for the MR-linac treatment in breast cancer patients eligible for APBI, regional lymph node irradiation or a radiotherapy boost on tumor positive lymph nodes. Furthermore, to investigate whether…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Develop optimal MRI-sequences and an on-line adaptive MRI-only treatment
planning workflow. 2) Investigate the feasibility of delineating tumor positive
lymph nodes on MRI registered with the standard diagnostic FDG-PET scan and
standard RT planning CT scan, compared to delineation based on standard RT
planning CT scan and standard diagnostic FDG-PET scan.
Secondary outcome
Not applicable.
Background summary
In breast radiotherapy (RT), accelerated partial breast irradiation (APBI),
instead of whole breast irradiation can represent less burdening alternatives
in selected low-risk patients with equivalent therapeutic efficacy and reduced
toxicity. Moreover, regional lymph node RT can replace axillary lymph node
dissection (ALND) in patients with tumor positive (sentinel) lymph nodes.
Current computed tomography (CT)-based image guided radiotherapy is not always
optimal for these treatment approaches. Due to uncertainties in target volume
definition on CT, relatively large RT treatment volumes are still required.
Furthermore, delineation of individual lymph nodes before RT treatment, might
be less accurate based on CT imaging. Magnetic resonance imaging (MRI) shows
higher soft tissue contrast and visualizes breast glandular tissue and (tumor
positive) lymph nodes better compared to CT. Hence, MRI techniques in RT supine
position have been developed at the department of Radiation Oncology in UMC
Utrecht, to visualize the tumor and axillary lymph nodes in breast cancer
patients. The results of this study [METC-protocol 14-447] have been published
recently. On MRI a significantly increased number of lymph nodes was visualized
compared to CT. Therefore, MRI may increase the precision of delineation of
individual (tumor positive lymph) nodes which could enable hypofractionated
dose escalation on the tumor positive lymph nodes instead of axillary surgery
or conventionally fractionated RT. Furthermore, the results from this study
showed that lymph node (LN) numbers on postoperative MRI were highly
reproducible compared to the preoperative MRI. For that reason, both pre- and
postoperative MRI scans could be used in the current study.
Recently, a hybrid system (MR-linac) consisting of a radiotherapy delivery
device and an integrated MRI scanner (1.5 Tesla (T)), has been installed at the
UMC Utrecht. The MR-linac has the potential to improve target definition and
imaging during irradiation enabling a higher RT dose due to decreased margins
and decreased RT target volumes. Therefore, the MR-linac may enable
non-invasive RT and/or a shorter (i.e. hypofractionated) RT schedule as an
alternative to current surgical treatment (e.g. in breast cancer patients
eligible for APBI or in selected patients with an indication for regional lymph
node irradiation). Consequently, treatment burden could be further minimized
and quality of life could be increased in these patients.
Study objective
To develop and evaluate an adaptive MRI-only workflow for the MR-linac
treatment in breast cancer patients eligible for APBI, regional lymph node
irradiation or a radiotherapy boost on tumor positive lymph nodes. Furthermore,
to investigate whether MRI, in addition to the standard FDG-PET scan and/or RT
planning CT scan only, can increase the accuracy in delineation of individual
tumor positive lymph nodes in patients with an indication for a RT boost on the
involved nodes.
Study design
Prospective imaging study.
Study burden and risks
No risks are expected for patients undergoing MRI given that they will be
screened according to the MRI safety criteria. Patients will undergo
non-contrast-enhanced MRI(s) of the breast or regional lymph nodes. The time
burden consists of one to three imaging procedures on different days, which
will each take approximately 30 to 90 minutes.
Patients with tumor positive lymph nodes on standard diagnostic FDG-PET and an
indication for RT are selected to undergo an additional RT planning CT scan.
Consequently, there will be an additional irradiation load of approximately
3.5-6.0 millisievert (mSv), which involves very low risk for the patient of
developing a second malignancy. The time burden of the RT planning CT scan will
consist of approximately 15 minutes.
The standard diagnostic FDG-PET scan in supine position will be used for
registration, and will not lead to additional risks.
The additional MRI scans (and RT planning CT scan if indicated) will not
interfere with the standard clinical practice and no treatment delay will
occur.
For the current patient population, no related benefits are expected. If the
study objectives can be achieved, future patients eligible for APBI, regional
lymph node RT or a RT boost on tumor positive lymph nodes, will benefit from a
non-invasive and shorter RT schedule on the MR-linac instead of surgery.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Female gender;
- *18 years old;
- Patients with cTis-4N0-3M0-1 breast cancer (before any treatment) or with pTis-4N0-3M0-1 breast cancer (postoperatively);
- Written informed consent provided.;Additional inclusion criterion for the MRI regional lymph nodes imaging arm and RT planning CT scan:
- Positive lymph nodes based on standard diagnostic ultrasound-guided fine needle aspiration.
- Tumor positive axillary lymph nodes on standard diagnostic FDG-PET scan:
o For preoperative study participation: on FDG-PET scan before start of any treatment;
o For postoperative study participation: on FDG-PET after neoadjuvant systemic therapy if neoadjuvant systemic therapy was given.
Exclusion criteria
- Legal incapacity;
- MRI exclusion criteria of the MRI safety group of Radiology (UMC Utrecht);
- Previously known inability to undergo the scanning procedure.;Additional exclusion criterion for patients in the regional lymph nodes imaging arm:
- Previous ALND and/or surgery of the supraclavicular region.;Additional exclusion criterion for patients in the breast imaging arm:
- Breast tumor > 3 cm;
- For postoperative study participation: large seroma volume during physical examination and/or on standard RT planning CT.
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 | NL56683.041.16 |