Clinical evaluation of a prototype drop-in probe for (robot-assisted) laparoscopic sentinel node biopsy

Clinical evaluation of a prototype drop-in probe for (robot-assisted) laparoscopic sentinel node biopsy - Evaluation of a drop-in probe for sentinel node biopsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45762

Enrollment

Registered

2017-09-14

Start date

2017-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

schildwachtklierprocedure bij prostaatkanker prostate cancer sentinel node biopsy

Interventions

On the morning of surgery, ICG-99mTc-nanocolloid will be injected intraprostatically. Lymphoscintigrams and SPECT/CT imaging will be performed to determine the number and location of the sentinel no

Drop-in probe

Laparoscopic surgery

Robotic surgery

Sentinel node biopsy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients > 18 years of age; - Patients with histologically proven prostate cancer; - Patients are clinically N0M0 or NxMx; - Patients are scheduled for (robot-assisted) laparoscopic procedure.

Exclusion criteria

Exclusion criteria: - Patients with a history of iodine allergy; - Patients with a hyperthyroid or thyroidal adenocarcinoma; - Patients with kidney insufficiency.

Design outcomes

Primary

Measure	Time frame
Intraoperative sentinel node detection using the drop-in probe.	—

Secondary

Measure	Time frame
-	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)