PET/CT and Sentinel Node in Oral Cancer

Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01136265

Acronym

PETNode

Enrollment

Registered

2010-06-03

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2011-01-11

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

Conditions

Oral Cancer

Keywords

dual-time PET/CT, sentinel node

Brief summary

In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers. The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.

Detailed description

These patients are normally preoperatively sent to a CT scan of the thorax and abdomen; in this study, this CT is replaced by a wholebody PET/CT scan. Afterwards, the patients goes to sentinel node lymphoscintigraphy and then to operation. By combining biomarkers and molecular imaging in patients with a clinically T1/T2N0M0 oral cancer, we want to characterize the tumor physiologically and correlate these physiological features to the clinical appearance of the cancer. Aims of the study: * can PET/CT in this patient group metastases with consequently change of treatment? * can fusion of SPECT/CT and PET/CT with calculation of standardized uptake value (SUV) indicate, how much tumor tissue there should be in a positive sentinel node to be detected by PET? * can dual-time PET scanning better determine lymph node metastases, than single-time PET scanning? * correlation between SUV in PET with molecular-biological findings both in the primary tumor and in metastases

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* biopsy-verified oral cancer * over 18 years of age

Exclusion criteria

* under 18 years of age * inable patients * pregnancy * known allergy to contrast agents * kidney insufficiency * other known cancer * diabetes mellitus * acute medical conditions such as acute infection, acute cardial or lung disease or other intercurrent diseases

Countries

Denmark

Outcome results