Non-inferiority in operation time when using 3D SPECT/CT imaging, compared to standard 2D imaging, during sentinel node procedure for breast cancer patients

Non-inferiority in operation time when using 3D SPECT/CT imaging, compared to standard 2D imaging, during sentinel node procedure for breast cancer patients - SPECT/CT in sentinel node procedure breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51306

Enrollment

Registered

2022-03-24

Start date

2022-04-08

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

breast cancer + mammary carcinoma

Interventions

participants in the intervention group receive • ALWAYS a SPECT/CT • NEVER a skin mark participants in the control group get • SOMETIMES a SPECT/CT • MOSTLY a skin mark

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: breast cancer patient Slingeland Ziekenhuis eligible for sentinel node procedure adult female

Exclusion criteria

Exclusion criteria: previous surgery in the thorax area multifocal or multicentric tumors MARI procedure (in that case a SPECT/CT is always done)

Design outcomes

Primary

Measure	Time frame
primary outcome = operation time (in minutes and seconds) for the removal of the sentinel nodes = composite outcome: 1. Time needed to determine site of first incision • start time = moment when surgeon starts searching with gamma probe along the axillary skin for a signal from a sentinel node, to determine the location of the first incision • end time = moment when surgeon returns the probe and makes the first incision 2. Time needed to find and remove all sentinel nodes • start time = moment of first incision • end time = time when the last stitch closes the incision that was made to remove sentinel nodes	—

Measure

Time frame

primary outcome = operation time (in minutes and seconds) for the removal of the sentinel nodes = composite outcome: 1. Time needed to determine site of first incision • start time = moment when surgeon starts searching with gamma probe along the axillary skin for a signal from a sentinel node, to determine the location of the first incision • end time = moment when surgeon returns the probe and makes the first incision 2. Time needed to find and remove all sentinel nodes • start time = moment of first incision • end time = time when the last stitch closes the incision that was made to remove sentinel nodes

—

Secondary

Measure	Time frame
secundary outcoms: • total residence time in the Department of Nuclear Medicine (in minutes and seconds) • necessity for extra waiting time for Nuclear Medicine, due to insufficient visualization (yes/no) • length of the scar for the sentinel node procedure (in millimetres) • difference between the number of visualised and reported radioactive lymph nodes (sentinel nodes) on the one hand, and the number of radioactive lymph nodes actually removed on the other hand	—

Measure

Time frame

secundary outcoms: • total residence time in the Department of Nuclear Medicine (in minutes and seconds) • necessity for extra waiting time for Nuclear Medicine, due to insufficient visualization (yes/no) • length of the scar for the sentinel node procedure (in millimetres) • difference between the number of visualised and reported radioactive lymph nodes (sentinel nodes) on the one hand, and the number of radioactive lymph nodes actually removed on the other hand

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)