Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer.
Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer.
Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a
 positive impact in survival for patients with an increased genetic risk to develop pancreas
 cancer.

 In this study, following the indication of the swedish guidelines, consecutive patients with
 a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance
 Imaging (MRI) based. The results of this study were analyzed looking in the patients files
 collected during the screening period.
Pancreatic cancer is the 4th cause of cancer related deaths in USA and in many of the Western
 Countries. The incidence of the disease is almost corresponding to the mortality rate. For
 this reason pancreatic cancer can be considered a global lethal disease. Even if treatments
 have improved, the resection rate in patients suffering from ductal adenocarcinoma remain
 around 30% and the 5 years survival rates is below 20%. Because of the low incidence of
 pancreatic cancer in the general population, a population-based screening is not
 cost/effective. Anyway in the last two decades, data from literature demonstrate that
 pancreatic cancer can be the phenotypic expression of some know genetic syndromes and the
 existence of a familial risk to develop pancreatic cancer. In particular for this last
 condition, called familial pancreatic cancer (FPC), an increased risk is associated with the
 number of family member affected. In prospective epidemiological studies, is demonstrated
 that a positive family history of pancreatic cancer is present in about 10% of all
 consecutive probands. The identification of a population at risk, the suggestions that an
 early surgical treatment of pancreatic cancer can improve the prognosis and, in particular,
 the identifications of pre-neoplastic lesions as PanIN and IPMN associated to the natural
 history of FPC, contributed to the development on National and International guidelines for
 the surveillance of the individual at increased risk. Even do, today, no consensus is reached
 on inclusion criteria for a clinical surveillance program, screening modalities and target
 lesions. Traditionally individual with a 10 fold relative risk to develop pancreatic cancer
 were considered suitable for a screening program. However, more recently, the CAPS group
 suggested to include in a surveillance program individuals with a 5 fold higher relative
 risk. Early pancreatic cancer, IPMN and PanIN lesions are considered the target lesions of a
 clinical screening, however the concrete possibility to detect PanIN lesions during a
 surveillance program remain debatable and uncertain.The imaging modality technique used in
 the existing programs are, alone or in combination, magnetic resonance (MR), computed
 tomography (CT), endoscopic ultrasound (EUS), endoscopic retrograde cholagiopancreatography
 (ERCP). Anyway a tendency to use low aggressive modalities as MR and EUS is emerging by the
 recent recommendations. The results of the clinical studies are quite uncertain and difficult
 to compare due to different screening modalities and inclusion criteria. The yield of FPC
 screening programs published in literature range from 50 to 1.3%. The cost/effectiveness of a
 surveillance program for FPC is not already demonstrated.

 The aim of this study is to analyze the preliminary result of a prospective clinical
 surveillance program for individuals at risk for pancreatic cancer using a low aggressive, MR
 based, screening.

 Patients enrollment Patients with an increased "genetic" risk to develop pancreatic cancer
 will be enrolled in a MR surveillance program at Karolinska University Hospital.

 The patients were enrolled in the study from 3 different ways: relative of probands treated
 for pancreas cancer at karolinska University Hospital and with a positive family history of
 pancreatic cancer or with a positive anamnesis of an associated genetic syndrome, subjects,
 with a "genetically" increased risk, referred to us from other swedish centers, subjects
 referred to us by general partitioners.

 Inclusion criteria for the screening All the individuals with a 10 fold higher relative risk
 in respect to the general population to develop pancreatic cancer will be included in the
 study. In case of suspected known genetic syndromes, only patients with detected
 corresponding gene mutations will be enrolled.

 Screening modalities All patients fulfilling the inclusion criteria will be enrolled in the
 clinical study after a specific informed consent. Basically a complete familial and personal
 anamensis (including the pedegree) and a clinical examination will be obtained from all the
 patients. A blood sample will be collected into a bio-bank at Karolinska University Hospital.
 An MR/MRCP with secretin will be performed for all the patients. If the result of the MR are
 negative (no findings detected) a one year screening, with the same modalities is
 recommended. Only patients with some anomaly at the MR will undergo EUS with or without FNA
 and/or MDCT scan. Patients with a positive anamnesis suggestive for a known genetic syndrome
 will be offered specific genetic tests (BRCA1/2, SPINK1, PRSS1, p16, STK11) and respective
 genetic counselling.

 Target lesions of the screening Due to the low specificity and sensibility of the available
 technique in order to detect PanIN lesions, the lobulocentric atrophy areas are not
 considered a target of our screening. Macroscopic pre-neoplastic lesions (IPMN) or pancreatic
 solid mass are considered the only lesions suitable for detection and screening.
Inclusion Criteria:

 -  10 fold higher risk to develop pancreatic cancer

 -  Obtained informed consent

 Exclusion Criteria:

 -  age less than 18 yrs

 -  No consensus obtained