PET-CT lymphoscintigraphy for sentinel node detection in head and neck cancer: a feasibility study

PET-CT lymphoscintigraphy for sentinel node detection in head and neck cancer: a feasibility study - PET-SN

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39155

Enrollment

Registered

2011-11-01

Start date

2012-04-18

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

head and neck cancer head and neck squamous cell carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Early stage oral cavity carcinoma (T1-2, cN0) scheduled for transoral excision and sentinel node procedure (Part A) * Oral cavity carcinoma (maximum tumor size 4 cm) which are scheduled for more extensive surgery including neck dissection, e.g. for patients with proven lymph node metastases (max. N1 disease) or patients in which the primary tumor cannot be resected transorally and for which the neck is opened for reconstruction purposes (Part B) * Age>18 years * Previously untreated * Written informed consent

Exclusion criteria

Exclusion criteria: 1. presence of nodal disease in the neck (PART A);2. prior treated by radiotherapy, chemotherapy, or surgery in the head and neck area;3. pregnancy

Design outcomes

Primary

Measure	Time frame
identification rate of sentinel nodes as depicted by PET-CT compared to conventional planar lymphoscintigraphy. (PART A) Evaluation of intraoperative detection of 89Zr-Nanocoll containing lymph nodes using a PET-probe. (PART B)	—

Secondary

Measure	Time frame
-number and localisation of sentinel nodes on both imaging modalities (PET-CT and conventional) -additional value of PET-CT -evaluation of PET-probe guided detection and resection of sentinel nodes	—

Countries

Netherlands

Outcome results