Feasibility of PET probe guided extirpation of FDG-PET positive lymph nodes which are negative on other imaging modalities in head and neck cancer patients scheduled for primary irradiation.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility to extirpate these FDG-PET lymph nodes.
Secondary outcome
Diagnostic accuracy of PET-CT in these by other imaging techniques negative
lymph nodes.
Chance of radiation planning.
Background summary
If all FDG-PET positive lymph nodes receive high dose irradiation the chance of
overtreatment with potential side effects will be about 25%. If the other
imaging modalities are negative the tumor load in the lymph nodes will probably
be low, e.g. micrometastases. If these FDG-PET positive nodes can be
identified, extirpated and investigated similar to the sentinel node biopsy
procedure overtreatment can be avoided.
Study objective
Feasibility of PET probe guided extirpation of FDG-PET positive lymph nodes
which are negative on other imaging modalities in head and neck cancer patients
scheduled for primary irradiation.
Study design
Prospective, observational pilot study of 20 patients.
Intervention
FDG-PET/CT
Lymph node extirpation under general anesthesia guide by PET-probe
Study burden and risks
In current clinical practice these patients will receive high dose radiation on
FDG-PET positive lymph node of which it is not clear if this lymph node
contains metastatic cells. If the nature of this FDG positive lymph node is
clear, a correct radiation dose can be given, avoiding futile radiation to
normal tissue which may decrease toxicity.
The exposure to radioactivity by FDG will be low compared to the radiation
treatment. The lymph node extirpation will be performed by an head and neck
surgeon experienced with the sentinel node biopsy in the head and neck. In the
literature on head and neck cancer no serious adverse events have been reported
using these techniques. Lymph node extirpation will be performed under general
anaesthesia.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
• Patients with a primary biopsy proven head and neck cancer scheduled for primary irradiation with or without chemotherapy
• Lymph nodes which are positive on FDG-PET but negative on other imaging modalities
• Ultrasound guided fine needle aspiration cytology of these FDG-PET positive lymph nodes remains negative if performed after the results. This procedure must be performed afterwards if FDG-PET reveals these unexpected FDG-PET positive lymph nodes.
• FDG-PET positive lymph nodes have impact on radiation treatment planning if based on FDG-PET as judged by the radiation oncologist.
• *Informed consent* signed by patient
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30458.029.09 |