Simplifying the sentinel node procedure in breast cancer using a portable gamma camera in order to replace conventional preoperative lymphatic mapping.

Simplifying the sentinel node procedure in breast cancer using a portable gamma camera in order to replace conventional preoperative lymphatic mapping. - SENTIMAP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45614

Enrollment

236

Registered

2017-06-30

Start date

2017-11-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymph node Sentinel node

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 2nd primary in ipsilateral breast Breast cancer recurrence in ipsilateral breast DCIS and LCIS

Design outcomes

Primary

Measure	Time frame
The main endpoint is the SN detection rate using the PGC in breast cancer compared to the current method, CGC imaging.	—

Secondary

Measure	Time frame
* 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.	—

Measure

Time frame

* 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.

—

Countries

Netherlands

Outcome results