Research question: Is microbubble-enhanced Iodine-125 seed localization an accurate tool for preoperative identification of the sentinel lymph node in women with breast cancer, in terms of diagnostic accuracy, sensitivity, feasibility, patient…
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
Detection rate of microbubble-enhanced Iodine-125 seed localization of SLN,
defined as the number of patients in whom the microbubble-enhanced SLN and the
technetium-99m enhanced SNL are the same.
Secondary outcome
Secondary outcomes
- Sensitivity of microbubble-enhanced I-125 seed localization: [number of
patients with microbubble detected metastatic SLNs] / [total number of patients
with axillary lymph node metastases]
- Technical feasible microbubble-enhanced I-125 seed localization of SLN:
successful visualization of SLN, successful I-125 seed placement and excision
of I-125 seed without migration or seed loss
- Preoperative concordance of microbubble and technetium-99m enhanced SLNs,
imaged with SPECT/CT
- Duration of procedures and hospitalization
- Patients pain and comfort scores: microbubble-enhanced versus technetium-99m
guided localization of SLN
- Surgeon*s / radiologists preferences and opinions
Tertiary outcomes
For the subgroup of patients with non-palpable lesions, we will estimate the
proportion of patients for whom plannable surgery could have been achieved.
Here plannable surgery will be defined as successful preoperative localisation
of both the primary tumor (image-guided Iodine-125 seed placement) and the
sentinel node (microbubble-guided Iodine-125 seed placement).
Background summary
In the Netherlands, the majority of breast cancers are detected as early, often
nonpalpable lesions, which are amenable to breast conserving surgery and
technetium-99m nanocolloid enhanced sentinel lymph node (SLN) biopsy. Even
though extremely accurate, this procedure is associated with complicated, time
and resource consuming and rather patient unfriendly logistics. Microbubble
enhanced Iodine-125 (I-125) seed localization of the SLN is a promising
alternative, which would allow complete preoperative work-up days or weeks
before the actual surgical intervention.
With the current study, we aim to evaluate whether microbubble enhanced I-125
seed localization of the SLN is a feasible and reliable alternative for
technetium-99m enhanced sentinel lymph node biopsy.
Study objective
Research question: Is microbubble-enhanced Iodine-125 seed localization an
accurate tool for preoperative identification of the sentinel lymph node in
women with breast cancer, in terms of diagnostic accuracy, sensitivity,
feasibility, patient comfort and logistics?
This study will allow us to find out whether microbubble-enhanced ultrasound
guided I-125 seed placement is a feasible, accurate and a safe way to
preoperatively identify the SLN in patients with breast cancer planned for
sentinel lymph node biopsy. With positive results, we would have developed a
method to localize both the primary tumour and SLN in one session, days or even
weeks before the surgical intervention. Plannable breast conserving treatment
would be of great advantage, both from patients, doctors and societal
perspective. The patient would be spared a logistically complicated and time
consuming intervention. Radiologists and nuclear medicine physicians would no
longer be forced to work in narrow time frames. With patients completely worked
up before surgery, surgeons are given the possibility for more efficient
planning of surgical interventions, allowing more surgical interventions in one
day, which could reduce waiting lists and costs.
Study design
Study design - Cross-sectional
Setting - Multicenter
Duration - 24 months
Study burden and risks
Participating patients will undergo three extra procedures and will be asked to
complete one questionnaire.
The first two extra procedures are microbubble injection for localization of
the SLN and subsequent percutaneous placement of an I-125 seed. The risk of the
microbubble injection consists of allergic reactions and should not be used in
patient with a recent acute coronary syndrome or unstable ischemic heart
disease.
There is a negligible activity and level of radiation from the I-125 seed. The
I-125 seed is placed up to a few hours before surgery. Due to this low activity
as well as the shielding provided by the body, patients are not required to
take any special precautions.
The SPECT/CT scan is performed in the same area as the radiotherapy treatment
field.
The questionnaire will be conducted after the preoperative procedures. The
questionnaire will provide information on patients pain and comforts scores.
The microbubble enhanced I-125 seed placement is compared to the *standard*
localization of the sentinel lymph node with technetium-99m. The Visual
Analogue Scale is used for pain scores and comfort is recorded using a Likert
Scale (0-5).
There are no direct benefits of participation for the patients recruited into
this study. If successful, this study will achieve plannable breast conserving
surgery and therefore be of great value for future breast cancer patients.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Females, aged 18 years or older
- Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy
Exclusion criteria
- Male patients
- Histologically or cytologically proven axillary lymph node involvement
- Recurrent disease
- Indication for ALND
- Pregnancy or lactation
- Sentinel lymph node biopsy after neoadjuvant treatment
- Recent acute coronary syndrome or unstable ischemic heart disease*
- Severe lung disease* and shortness of breath
- Unstable neurologic disease, acute endocarditis, artificial heart valves, acute systemic infection, tromboembolic disease, advanced liver or kidney failure
- Mentally incompetent patients;* SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg, uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome. Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000333-40-NL |
| CCMO | NL38677.041.12 |
| OMON | NL-OMON27431 |