The use of fluorescent tracers in treatment of head and neck cancer

The intraoperative use of fluorescent tracers and multimodal imaging techniques in treatment of head and neck cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003578-28-DK

Enrollment

Unknown

Registered

2013-10-21

Start date

2013-10-21

Completion date

Unknown

Last updated

2017-03-13

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

Conditions

oral cavity cancer MedDRA version: 14.1 Level: LLT Classification code 10030961 Term: Oral cancer stage unspecified System Organ Class: 100000004864

Interventions

Trade Name: ICG-Pulsion Product Name: ICG-Pulsion Product Code: PICG0050UK Pharmaceutical Form: Powder for injection INN or Proposed INN: Indocyanine Green CAS Number: 3599-32-4 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primary squmous cell carcinoma in the oral cavity scheduled for tumor resection and sentinel node biopsy or neck dissection Age over 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Prior head and neck cancer Prior radiotherapy or surgery in the neck Mental illness Prenancy or Lactation severe kidney failure Known allergy to Indocyanin Green or Iodine Knowm hyperthyrodisme Scintigraphy and SPECT CT unsuitble for interpretation

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine and implement the intraoperative use of fluorescent tracers and optical imaging in the treatment of oral cancer.;Secondary Objective: •Examine if a near-infraread (NIR)-camera and the tracer *Tc:Nanocoll:ICG can increase the accuracy of SNB in patients with oral cancer T1-T2N0M0 compared to the present radioactive tracer. •Examine if a NIR-camera and the tracer Nanocoll:ICG can improve the radicality of neck dissection by intraoperative and ex vivo visualization of lymph nodes in patients with oral cancer and lymph node metastases. ;Primary end point(s): 1) Ddetection rate defined as the number of sentinel nodes removed divided by the number of sentinel nodes defined preoperatively on SPECT-CT. 2) The total amount of lymph nodes removed by each neck dissection pr. neck side. ;Timepoint(s) of evaluation of this end point: For both primary endpoints in two cohorts of patients the evaluation time will be after the completion of inclusion of all patients and data analyses. Is expected to be in november 2015.	—

Measure

Time frame

Main Objective: To examine and implement the intraoperative use of fluorescent tracers and optical imaging in the treatment of oral cancer.;Secondary Objective: •Examine if a near-infraread (NIR)-camera and the tracer *Tc:Nanocoll:ICG can increase the accuracy of SNB in patients with oral cancer T1-T2N0M0 compared to the present radioactive tracer. •Examine if a NIR-camera and the tracer Nanocoll:ICG can improve the radicality of neck dissection by intraoperative and ex vivo visualization of lymph nodes in patients with oral cancer and lymph node metastases. ;Primary end point(s): 1) Ddetection rate defined as the number of sentinel nodes removed divided by the number of sentinel nodes defined preoperatively on SPECT-CT. 2) The total amount of lymph nodes removed by each neck dissection pr. neck side. ;Timepoint(s) of evaluation of this end point: For both primary endpoints in two cohorts of patients the evaluation time will be after the completion of inclusion of all patients and data analyses. Is expected to be in november 2015.

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Secondary

Measure	Time frame
Secondary end point(s): operation time, feasibility and fluorescent intensity of lymph nodes.;Timepoint(s) of evaluation of this end point: For the secundary endpoints in two cohorts of patients the evaluation time will be after the completion of inclusion of all patients and data analyses. Is exspected to be in november 2015.	—

Countries

Denmark

Contacts

Public ContactDepartment of Clinical Physiology,

Rigshospitalet

andreas.kjaer@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026