Een prototype opto-nuclear probe voor gecombineerde radio- en fluroescentie geleide identificatie van de schildwachtklier(en)

A prototype opto-nuclear probe for combined radio- and fluorescence tracing of the sentinel node

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27231

Enrollment

Registered

2014-08-12

Start date

2014-08-01

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

sentinel lymph node biopsy, prostate cancer, penile cancer, head and neck melanoma, oral cavity cancer

Interventions

According to the current standard, on the afternoon prior to, or on the morning of surgery, ICG-99mTc-nanocolloid will be injected peritumorally sub- or intracutaneously (patients with prostate cancer

Eligibility

Inclusion criteria

Inclusion criteria: - Patients > 18 years of age; - Patients with histologically proven head and neck malignancies; - Patients with histologically proven penile cancer; - Patients with histologically proven prostate cancer; - Patients are clinically N0M0 (penile cancer: N0M0 or N1M0); - For head and neck malignancies and penile cancer patients only: Patients are scheduled for (primary) tumor (scar) removal with a subsequent sentinel node biopsy; - For prostate cancer patients only: Patients with an increased risk of nodal metastases according to the Briganti nomogram (>10%); - For prostate cancer patients only: Patients are scheduled for (robot-assisted) laparoscopic prostatectomy with a subsequent sentinel node biopsy procedure and selective lymph node dissection.

Exclusion criteria

Exclusion criteria: - History of iodine allergy; - Hyperthyroid or thyroidal adenoma; - Kidney insufficiency.

Design outcomes

Primary

Measure	Time frame
-Determination of the sensitivity and specificity of the open-procedure opto-nuclear probe for sentinel node(s) identification using the combination of radio- and fluorescence tracing. Obtained results will be compared to those obtained using the conventional method(s); -Determination of the sensitivity and specificity of the laparoscopic opto-nuclear probe for sentinel node(s) identification using the combination of radio- and fluorescence tracing. Obtained results will be compared to those obtained using the conventional method(s).	—

Measure

Time frame

-Determination of the sensitivity and specificity of the open-procedure opto-nuclear probe for sentinel node(s) identification using the combination of radio- and fluorescence tracing. Obtained results will be compared to those obtained using the conventional method(s); -Determination of the sensitivity and specificity of the laparoscopic opto-nuclear probe for sentinel node(s) identification using the combination of radio- and fluorescence tracing. Obtained results will be compared to those obtained using the conventional method(s).

—

Secondary

Measure	Time frame
- Identification of (tumor positive) sentinel node(s) using the opto-nuclear probe for open procedures; - Identification of (tumor positive) sentinel node(s) using the opto-nuclear probe for laparoscopic procedures.	—

Contacts

Public ContactH.G. Poel, van der

Department of Urology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Plesmanlaan 121

h.vd.poel@nki.nl+31205129111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)