The primary objective is to evaluate the SN detection rate of the PGC in breast cancer compared to CGC imaging.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the SN detection rate using the PGC in breast cancer
compared to the current method, CGC imaging.
Secondary outcome
* Correlation of the SN detection rate with patients subgroups (tumor type,
T-stage, etc.)
* Utilization of the PGC by nuclear medicine technicians and breast surgeons
and the effects on logistics and work-flow at the department of Nuclear
Medicine;
* PGC SN detection rates correlated to PGC imaging acquisition times.
* PGC image quality compared to CGC image quality: SN visualization score (0=no
uptake, 1=weak, 2=moderate, 3=intense);
* A subjective descriptive analysis of the novel hybrid aspect of the PGC
where an optical image is combined with a scintigraphic image to combine
functional and anatomical information in a fused image output.
Background summary
The sentinel lymph node biopsy (SLNB) is a surgical procedure that can be used
to stage the disease in breast cancer. The procedure includes a pathological
examination of the first lymph node draining from the tumor, the sentinel node
(SN). This node is visualized at the department of Nuclear Medicine and is
removed for pathological analysis during surgery. A radiotracer is administered
in the breast and currently two imaging acquisitions are performed in order to
visualize the SN: fifteen minutes and three hours after injection using a
conventional gamma camera (CGC). Thereafter, the Nuclear Medicine physician
reports the number of nodes and their location to the surgeon. The current
imaging procedure at the department of Nuclear Medicine is time-consuming. A
smaller, high-resolution portable gamma camera (PGC) is available that could
simplify the imaging procedure. This may lead in clinical practice to
substitution of the use of the CGC by use of PGC, provided it yields the same
SN detection rate as the CGC.
Study objective
The primary objective is to evaluate the SN detection rate of the PGC in breast
cancer compared to CGC imaging.
Study design
Single center prospective observational research
Study burden and risks
There are no immediate risks expected as a result of the additional imaging.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Woman
Proven primary breast cancer
Scheduled for sentinel node procedure at the department of Nuclear Medicine
Able to provide informed consent
Exclusion criteria
2nd primary in ipsilateral breast
Breast cancer recurrence in ipsilateral breast
DCIS and LCIS
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 | NL60147.031.16 |