The primary objective is to show that the ORION SYSTEM is safe and performs as intended.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Performance. Number and percentage of procedures in which ORION SEEDS is
present on post-operative specimen X-ray and only the ORION detector is used
during surgery [=>95%]
2) Safety. Adverse events as assessed by MedDRA.Number and percentage of
patients who experienced a device-related adverse event. [No SADEs]
Secondary outcome
In situ time Days between implantation and surgery [all cases <30 days]
Accuracy of placement - Average distance between centre of SEED and centre of
lesion measured on two-way mammography in mm [descriptive]
Sonographic Tumour depth - Minimum distance between skin and tumour border on
ultrasound imaging (mm) [descriptive]
Sonographic Tumour size - Shortest and longest axis of tumour on ultrasound
(mm) [descriptive]
Radiologist Satisfaction - Satisfaction as measured on a questionnaire [see
Appendix A]
Operative time - Minutes from first incision until excision of specimen
[descriptive]
Transcutaneous detection - Number and percentage of procedures in which a
reliable signal is measured on the intact skin preoperatively.
Also note the value. [*95% of cases]
Seed Confirmation - Seed detected in excised specimen using ORION detector
[descriptive]
Surgeon Satisfaction - Satisfaction as measured on a questionnaire
Patient Convenience - Patient convenience reported measured using a single
quesiton
Margin Status - Margin status defined per NABON Dutch national guidelines
[descriptive]
Reoperation - Second, separate surgical procedure of same lesion or area
indicated after multidisciplinary discussion [descriptive]
Background summary
The introduction of population-wide mammographic screening programmes for
breast cancer has led to an increase in the incidence of screen-detected,
non-palpable breast cancer. Breast conserving surgery (BCS) is the treatment
of choice for these lesions [1], but this can be challenging and often requires
pre-operative radiological localization to guide the surgeon towards the tumour
location.
Wire guided localization (WGL) has been the gold standard for tumour
localization since its first description in the 1970s [2]. In WGL, a metal
anchor wire is placed in the tumour generally on the day of surgery. During
surgery, the surgeon follows this wire from the skin to resect the tissue
surrounding the tip.
Unfortunately, WGL is associated with disadvantages for all involved
stakeholders: Surgeons have limited guidance towards the lesion as they are
forced to follow the wire trajectory from the skin leading to undesirable
incision locations and extensive dissection of healthy tissue[3]. Moreover, the
wire may displace prior to or during surgery [4]. Hospitals are faced with
logistical issues as patients need to visit the radiological department for
wire placement prior to, but on the same day of surgery [5]. Coupling these
schedules frequently leads to delays[3]. Patients need to undergo two stressful
procedures on the day of surgery and have a wire protruding from their breast
while awake which is painful [6].
Due to these well described disadvantages, radio guided technologies such as
Radioactive Seed Localization (RSL) have been introduced as a challenging
alternative to WGL and over the past decade found traction in the market.
In RSL, a tiny radioactive iodine-125 seed is preoperatively implanted into
the lesion and removed during surgery using a handheld radioactive (gamma)
detector)[5]. As such, RSL allows for surgical flexibility as surgeons can
assess and reassess their approach independently; it decouples radiology and
surgical schedules as the seed can be placed well in advance of surgery which
improves logistics [7] and eliminates the need for two stressful procedures on
the operative day which is preferred by patients [6].
However, the use of radioactive seeds is associated with its own set of
limitations. Regulations regarding the safe procurement, use and disposal of
these seeds are very strict and the penalties for example when losing a seed
are severe, which hampers wide-spread uptake. Moreover, radioactive isotopes
are scarce and according to the European Commission *there is a need to further
explore possibilities for alternatives to radiopharmaceuticals in the EU* [8].
Sirius Medical Systems is a spin-out from the University of Twente (UTwente;
Enschede, NL) and the Netherlands Cancer Institute * Antoni van Leeuwenhoek
Hospital (NKI-AvL; Amsterdam, NL). At the NKI, a novel localization technology
was developed that uses the principle of magnetism, rather than radioactivity
[9]. Clinical investigations with a predecessor device and a commercially
available magnetic detector have been performed and published [10].
However, this detector was limited by a detection depth of 3cm, provides
relative count values only, requires the use of plastic surgical instruments as
the signal is heavily influenced by conducting metal and needs frequent
(re)calibration.
Sirius has further refined NKI*s magnetic technology, and developed an improved
magnetic seed and detector that together provide an improved detection distance
of 5 cm, absolute distance measurement towards the seed in mm, is not
influenced by surgical steel and does not need recalibration during the
procedure. The system is called ORION .
The objective of the current study is to show that this novel technology is
safe and performs as intended for localization of early-stage (non-palpable)
breast cancer. The results of this study will be used to obtain CE mark for
this device.
[1] U. Veronesi et al., *Twenty-year follow-up of a randomized study comparing
breast-conserving surgery with radical mastectomy for early breast cancer.,* N.
Engl. J. Med., vol. 347, no. 16, pp. 1227*32, Oct. 2002.
[2] H. A. Frank, F. M. Hall, and M. L. Steer, *Preoperative Localization of
Nonpalpable Breast Lesions Demonstrated by Mammography,* N. Engl. J. Med., vol.
295, no. 5, pp. 259*260, Jul. 1976.
[3] L. J. McGhan et al., *Radioactive seed localization for nonpalpable breast
lesions: review of 1,000 consecutive procedures at a single institution.,* Ann.
Surg. Oncol., vol. 18, no. 11, pp. 3096*101, Oct. 2011.
[4] P. J. Lovrics et al., *A multicentered, randomized, controlled trial
comparing radioguided seed localization to standard wire localization for
nonpalpable, invasive and in situ breast carcinomas.,* Ann. Surg. Oncol., vol.
18, no. 12, pp. 3407*14, Nov. 2011.
[5] R. J. Gray et al., *Randomized prospective evaluation of a novel technique
for biopsy or lumpectomy of nonpalpable breast lesions: radioactive seed versus
wire localization.,* Ann. Surg. Oncol., vol. 8, no. 9, pp. 711*5, Oct. 2001.
[6] J. S. L. Ong et al., *Patient satisfaction with Radioguided Occult Lesion
Localisation using iodine-125 seeds ('ROLLIS*) versus conventional hookwire
localisation,* Eur. J. Surg. Oncol., vol. 43, no. 12, pp. 2261*2269, 2017.
[7] L. Langhans et al., *Radioactive Seed Localization or Wire-guided
Localization of Nonpalpable Invasive and In Situ Breast Cancer: A Randomized,
Multicenter, Open-label Trial.,* Ann. Surg., vol. 266, no. 1, p. 1, 2017.
[8] European Commission, *Preliminary Report on Supply of Radioisotopes for
Medical Use and Current Developments in Nuclear Medicine,* 2009.
[9] B. Schermers, ten H. Bennie, S. Muller, J. A. van der Hage, and T. J. M.
Ruers, *Optimization of an implantable magnetic marker for surgical
localization of breast cancer,* Biomed. Phys. Eng. Express, vol. 4, no. 6, 2018.
[10] B. Schermers et al., *Feasibility of magnetic marker localisation for
non-palpable breast cancer,* The Breast, vol. 33, pp. 50*56, 2017.
Study objective
The primary objective is to show that the ORION SYSTEM is safe and performs as
intended.
Study design
Premarket, open label, single-centre, prospective clinical interventional trial
Intervention
In the training phase, patients will receive both the standard treatment
(radioactive seed localization) and the investigational treatment (magnetic
seed localization). This means one additional puncture at the department of
radiology during a standard treatment session.
In the study phase, patients will receive only the investigational treatment
(magnetic seed localization). The activities pertaining to the standard
treatment (implantation of a radioactive seed; surgery using a radioactive
detector) will be replaced by comparable activities for the investigational
treatmen (implantation of a magnetic seed; surgery using a magnetic detector).
Study burden and risks
Burden for training cases (combination of standard treatment and
investigational treatment); additional puncture at the department of radiology
during a routine procedure; answering a single question.
Burden for study patients: answering a single question
Risks associated with participation are risks that generally belong to placing
a tiny radiological implant:
* Local hematoma after implantation
* Local seroma after implantation
* local infection after implantation
* Pain
High Tech Campus 41
Eindhoven 5656AE
NL
High Tech Campus 41
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
1. Patient is willing and able to provide informed consent for the
investigation and to comply to the schedule of assessments of the clinical
investigation
2. Patient is female
3. Patient is at least 18 years of age
4. Patient is diagnosed with a single, pathologically confirmed unifocal breast
tumour (DCIS or invasive)
5. Tumour is ultrasound visible
6. Patient is indicated for primary breast conserving surgery
7. Patient is indicated for preoperative localization using a single
(radioactive) seed
Exclusion criteria
1. Patient is pregnant;
2. Patient is receiving neo-adjuvant chemotherapy
3. Patient has and ICD or other active implant such as a pacemaker less than
5cm away from the intended target location
4. Patient has a proven infection or hematoma at or close to the intended
target location
5. Patient is scheduled for immediate breast reconstruction (within the same
surgical procedure)
6. Patient is currently participating in, or has recently exited from, or plans
to be enrolled in another clinical investigation which may affect the outcomes
of the current clinical investigation, as assessed by the discretion of the
investigator
7. Patient is expected to require an MRI scan of the breast area in the period
between implantation and surgery
8. The expected time between placement of ORION SEED and surgery exceeds 30
days
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 |
|---|---|
| CCMO | NL69460.028.19 |
| Other | NL7630 |
| OMON | NL-OMON24152 |