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NCT Number: NCT01485679

18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.

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Key information

Conditions

Tumor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nord, Amiens, France

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About this study

Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with age equal or above 18
  • Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
  • if woman being of childbearing potential, woman taking contraceptive measures
  • Patient able to understand benefits and risks of protocol
  • Subject affiliated to French health insurance (Social Security)
  • Informed consent form signed

Exclusion criteria

  • Patients not fulfilling inclusion criteria
  • Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
  • Chemotherapy within 2 the months preceding the TEP-CT
  • Acute pancreatitis within 2 the months preceding the TEP-CT
  • Pregnant women or breast-feeding women refusing to temporary stop it
  • Diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (HbA1c) at inclusion) or Fasting blood glucose below 7mmol/L (126 g/L before the TEP)
  • Patients with claustrophobia
  • Patients not accepted under the anesthesia point of view

Treatment and study plan

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Other

18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography

Primary outcomes

  1. Specificity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.

    Time frame: 3 months

    TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas.

    The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma".

    Results will then be compared in term of specificity.

Secondary outcomes

  1. Sensitivity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.

    Time frame: 3 months

    TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas.

    The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma".

    Results will then be compared in term of sensitivity.

  2. Comparison of specificity of the TEP-CT to detect malignant lesions in pancreas versus specificity of conventional devices, the gold standard being the anatomopathological analysis results

    Time frame: 3 months

    Result of conventional devices (such as computed tomography, magnetic resonance cholangiopancreatography or endoscopic ultrasound) will be considered positive if diagnosis is "malignant lesion" or "probable malignant lesion". The 5 parts of the pancreas will be examined.

  3. Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Evaluation of 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2011
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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