Detection of sentinel lymph nodes in laryngeal cancer by injection of 99mTc-nanocolloid via flexible laryngoscopy as a new technique

Detection of sentinel lymph nodes in laryngeal cancer by injection of 99mTc-nanocolloid via flexible laryngoscopy as a new technique - 99mTc-nanocolloid in laryngeal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51411

Enrollment

Registered

2023-01-19

Start date

2022-09-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Laryngeal cancer Laryngeal carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - proven carcinoma of the larynx - > 18 yrs of age - undergo a TL with planned neck dissection. - informed consent

Exclusion criteria

Exclusion criteria: - history of 99mTc-nanocolloid or human albumin allergy or anaphylactic reactions - (potential) pregnancy or lactating women

Design outcomes

Primary

Measure	Time frame
Feasibility of injecting 99mTc-nanocolloid via a routinely used flexible laryngoscope with a working channel will be evaluated by pre-operative imaging and measuring 99mTc-nanocolloid activity at the injection site and in regional lymph nodes. Subsequently diagnostic accuracy of the used technique (sensitivity, specificity, positive and negative predictive value and diagnostic accuracy) for detection of SLN will be calculated by using histopathological results as gold standard.	—

Measure

Time frame

Feasibility of injecting 99mTc-nanocolloid via a routinely used flexible laryngoscope with a working channel will be evaluated by pre-operative imaging and measuring 99mTc-nanocolloid activity at the injection site and in regional lymph nodes. Subsequently diagnostic accuracy of the used technique (sensitivity, specificity, positive and negative predictive value and diagnostic accuracy) for detection of SLN will be calculated by using histopathological results as gold standard.

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Secondary

Measure	Time frame
Preoperative located SLN via gamma camera imaging will be compared to intraoperative located SLN using a gamma probe.	—

Countries

Netherlands

Outcome results