PET/CT and Sentinel Node in Oral Cancer

NCT ID: NCT01136265

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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

Conditions

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Oral Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Dep. of Nuclear Medicine & PET, Rigshospitalet

Principal Investigators

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Christine W Dümcke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Nuclear Medicine & PET

Locations

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Dep. of Nuclear Medicine & PET

Copenhagen, , Denmark

Site Status

Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RH-238_10

Identifier Type: -

Identifier Source: org_study_id

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