Sentinel node biopsy for bladder cancer using the hybrid tracer

Sentinel node biopsy for bladder cancer using the hybrid tracer - Hybrid sentinel node biopsy for bladder cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41181

Enrollment

Registered

2014-11-03

Start date

2014-10-08

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Bladder cancer Bladder carcinoma

Interventions

On the day before surgery (approximately 18hours) patients will receive 4-6 transurethral injections with a total of 2mL hybrid tracer ICG-99mTc-nanocolloid (240MBq) around the tumor (in case of a s

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients >18 years with clinically localized bladder cancer Patients with proven histological-pathological bladder cancer Patients scheduled for brachytherapy or radical cystectomy with or without neo-adjuvant chemotherapy Patients with cN0 lymph node status

Exclusion criteria

Exclusion criteria: Patients with preoperatively known distant metastases (M1); Patients with clinically tumor positive nodes; Previous radiation therapy of the pelvis; Previous pelvic lymphadenectomy for other reasons such as urologic and gynecologic malignancies

Design outcomes

Primary

Measure	Time frame
To evaluate the accuracy of the SN biopsy for nodal staging in patients with muscle invasive bladder cancer.	—

Secondary

Measure	Time frame
• Evaluation of intraoperative fluorescence detection of the SNs; • Feasibility of intraoperative SPECT/CT-based navigation using the declipseSPECT system; • Feasibility of freehand SPECT-based navigation to the SN using the declipseSPECT navigation system.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)