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

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 - Optical sentinel node detection in prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44119

Enrollment

112

Registered

2013-03-27

Start date

2012-08-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

prostate cancer prostate carcinoma

Interventions

No special patient preparation is required. Approximately 4 hours prior to surgery ICG-99mTc-nanocolloid will be injected transrectally under ultrasound guidance into the prostate tumor as is routin

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Histologically proven prostate cancer * Increased risk of nodal metastases according to the MSKCC nomogram (> 10%) * Scheduled for surgical (laparoscopic) prostatectomy including nodal dissection

Exclusion criteria

Exclusion criteria: * History of iodine allergy * Hyperthyroid or thyroidal adenoma * Kidney insufficiency

Design outcomes

Primary

Measure	Time frame
Primary objective: Further validation of the sentinel node procedure for prostate cancer via ultrasound guided transrectal ICG-99mTc-nanocolloid injection surrounding the tumor tumor location will be determined following diffusion weighted MR imaging.	—

Secondary

Measure	Time frame
Secondary objective: Improving the ICG-99mTc-nanocolloid injection; an ultrasound guided intratumoral injection of ICG-99mTc-nanocolloid will be performed instead of a transrectal injection Tertiary objective: Improving the identification of lymphatic drainage patterns through a preoperative intraprostatic injection of fluorescein at the start of the surgical procedure. This fluorescein injection will be given to patients who also received an intratumoral injection of ICG-99mTc-nanocolloid in the morning (a total of 20 patients will be included that have already been included under the secondary study objective). Quaternary objective: Fluorescence imaging of paraffin-embedded prostate samples allows the determination of the tumor location with regard to the location of the ICG-99mTc-nanocolloid deposits	—

Measure

Time frame

Secondary objective: Improving the ICG-99mTc-nanocolloid injection; an ultrasound guided intratumoral injection of ICG-99mTc-nanocolloid will be performed instead of a transrectal injection Tertiary objective: Improving the identification of lymphatic drainage patterns through a preoperative intraprostatic injection of fluorescein at the start of the surgical procedure. This fluorescein injection will be given to patients who also received an intratumoral injection of ICG-99mTc-nanocolloid in the morning (a total of 20 patients will be included that have already been included under the secondary study objective). Quaternary objective: Fluorescence imaging of paraffin-embedded prostate samples allows the determination of the tumor location with regard to the location of the ICG-99mTc-nanocolloid deposits

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)