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Sentinel node localization in larynx and pharynx cancers after flexible endoscopy-guided tracer injection: a feasibilty study

Sentinel node localization in larynx and pharynx cancers after flexible endoscopy-guided tracer injection: a feasibilty study - FLEX-NODE study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48222
Enrollment
25
Registered
2019-07-30
Start date
2019-12-24
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

larynx- pharynx cancer throat cancer

Interventions

Application of the radioactive tracer: In patients who have given permission to take part in the project the H&N doctor will carry out an inspection of the tumor with the flexible scope such as is r

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -male or female aged > 18 years -mucosal tumor of the oropharynx, hypopharynx or larynx -patients planned to undergo biopsy via flexible endoscopy -patients planned to undergo curative radiotherapy with or without concurrent chemotherapy -patient provided written informed consent

Exclusion criteria

Exclusion criteria: -patients who underwent previous surgery or radiotherapy to the neck -patients with airway obstruction causing stridor -prior allergic reaction to Tc-99m-nanocolloid -pregnancy -unable to provide informed consent

Design outcomes

Primary

MeasureTime frame
A SPECT image of sufficient quality for localization of the sentinel node(s). This is a qualitative endpoint and is assessed by consensus between a nuclear medicine physician (A. Arens), head and neck surgeons (J. Honings, R. Takes, W. Weijs) and a radiation oncologist (J. Kaanders).

Secondary

MeasureTime frame
1. Is it feasible to administer at least 2 injections during the same procedure? 2. Can sentinel nodes identified by SPECT be recognized on routine CT or MRI?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)