Clinical trial NCT01136265: PET/CT and Sentinel Node in Oral Cancer
Official title: Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Keywords: dual-time PET/CT
sentinel node
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 consecutive patients with biopsy-verified oral cancer without a suspicion of metastases and without prior treated neck

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

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Nuclear Medicine & PET
city: Copenhagen
country: Denmark
facility: Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet
Study officials:
affiliation: Dep. of Nuclear Medicine & PET
name: Christine W Dümcke, Dr.
role: PRINCIPAL_INVESTIGATOR
References: