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Het gebruik van indocyanine groen voor de detectie van de schildwachtklier bij mannen met prostaatkanker met een hoog risico op klier metastasen. Wetenschappelijk onderzoek naar het verbeteren van de schildwachtklierprocedure voor prostaatkanker met behulp van fluorescentie

The use of indocyanine green for accurate sentinel node detection and removal in a group of high-risk nodal metastasis prostate cancer patients. To optimize and improve the sentinel node procedure in men with prostate cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20647
Enrollment
112
Registered
2014-02-24
Start date
2013-05-28
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

prostate cancer, sentinel node, lymph node, sentinel lymph node prostaat kanker, schildwachtklier, lymfeklier

Interventions

On the morning of surgery patients will receive an transrectal-ultrasound guided intraprostatic or intratumoral injection with the hybrid tracer ICG-99mTc-nanocolloid. Thereafter, preoperative imaging

Sponsors

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Plesmanlaan 121 1066CX Amsterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - patients >18 years of age - patients with histologically proven prostate cancer - patients with an increased risk of nodal metastasis according to the MSKCC nomogram (>10%) - scheduled for surgical (laparoscopic) prostatectomy including nodal dissection

Exclusion criteria

Exclusion criteria: - patients with a history of iodine allergy - patients with a hyperthyroid or thyroidal adenoma - patients with kidney insufficiency

Design outcomes

Primary

MeasureTime frame
Further validation of the sentinel node procedure for prostate cancer via an ultrasound-guided transrectal ICG-99mTc-nanocolloid. - Improve the intraoperative detection of the true tumor draining (tumor positive) sentinel nodes by improved injection techniques.

Secondary

MeasureTime frame
Improve sentinel node dissection using combined radio- and fluorescence guidance after injection of the hybrid tracer and (in a subset of patients) a subsequent fluorescein injection prior to the start of the surgical procedure.

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)