PET/CT and Sentinel Node in Oral Cancer

Oral Cancer Clinical Trial

— PETNode  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01136265
• Other study ID #: RH-238_10
• Status: Active, not recruiting
• Phase: N/A
• First received: June 2, 2010
• Last updated: January 10, 2011
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Locations

Country	Name	City	State
Denmark	Dep. of Nuclear Medicine & PET	Copenhagen
Denmark	Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark,