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Bladder cancer sentinel node mapping using ICG-99mTc-nanocolloid

Sentinel node mapping for bladder cancer using the hybrid tracer ICG-99mTc-nanocolloid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21640
Enrollment
30
Registered
2015-05-18
Start date
2015-07-01
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

Bladder cancer

Interventions

On the day before surgery (approximately 18 hours) patients will receive 4-6 transurethral injections with a total of 2mL hybrid tracer (240MBq) around the tumor (in case of a solitary lesion) or divi

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: - Patients >18 years; - Histopathologically proven bladder cancer; - Patients are cN0M0; - Patients scheduled for radical cystectomy with or without neo-adjuvant chemotherapy.

Exclusion criteria

Exclusion criteria: - Preoperatively known distant metastases (M1); - Clinically tumor-positive nodes; - Patients scheduled for brachytherapy of the bladder; - Previous radiation therapy of the pelvis; - Previous pelvic surgery for other reasons such as urologic and gynecologic malignancies (exception: trans-urethral operations like e.g. transurethral bladder resection).

Design outcomes

Primary

MeasureTime frame
Evaluate the accuracy of the sentinel node biopsy procedure for nodal staging in patients with non-metastatic (cN0M0) muscle-invasive bladder cancer.

Secondary

MeasureTime frame
1. Evaluation of the feasibility of sentinel node mapping in bladder cancer patients using the hybrid tracer (ICG-99mTc-nanocolloid); 2. Evaluation of intraoperative fluorescence detection of the SNs via fluorescence imaging; 3. Evaluation of the feasibility of sentinel node localization via intraoperative (SPECT/CT-based and freehandSPECT).

Contacts

Public ContactBas van Rijn

Plesmanlaan 121

b.v.rhijn@nki.nl020-512 2553

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)