Multicenter study evaluating the hybrid approach using a novel fluorescence camera - Identifying the value of intraoperative fluorescence imaging during sentinel node biopsy procedures

Multicenter study evaluating the hybrid approach using a novel fluorescence camera - Identifying the value of intraoperative fluorescence imaging during sentinel node biopsy procedures - Evaluating the hybrid approach during sentinel node biopsy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47277

Enrollment

125

Registered

2018-06-29

Start date

2018-07-02

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

schildwachtklierprocedure sentinel node biopsy

Interventions

On the morning of surgery, ICG-99mTc-nanocolloid will be injected peri- or intratumorally Lymphoscintigrams and SPECT/CT imaging will be performed to determine the number and location of the sentine

fluorescence

hybrid

imaging

sentinel node

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients >= 18 years; - Patients with a primary or recurrent breast cancer; - Patient with a primary melanoma; - Patients with a primary head-and-neck malignancy; - Patient with a primary or recurrent urological malignancy; - Patients with a primary or recurrent gynecological malignancy; - Patients present with negative regional lymph nodes (exception: vulvar and penile cancer: N1 patients are also eligible); - Patients that will undergo a sentinel node biopsy procedure.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- Determine the value of fluorescence imaging-guided surgery under ambient light conditions for the identification of hybrid tracer-containing SNs as seen on preoperative imaging.	—

Secondary

Measure	Time frame
- Determine the value (accuracy) of fluorescence imaging-assisted SN identification to the conventional radioguided approach; - Determine the value of fluorescence imaging-assisted SN identification to the conventional blue dye-based approach; - Evaluation of (post-operative) complications within 90 days after surgery (Clavien-Dindo score); - Evaluation of follow-up (local recurrence after SN biopsy).	—

Measure

Time frame

- Determine the value (accuracy) of fluorescence imaging-assisted SN identification to the conventional radioguided approach; - Determine the value of fluorescence imaging-assisted SN identification to the conventional blue dye-based approach; - Evaluation of (post-operative) complications within 90 days after surgery (Clavien-Dindo score); - Evaluation of follow-up (local recurrence after SN biopsy).

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)