Evaluation of the Diagnostic Value of TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer
Phase: NA
Conditions: Pancreatic Cancer, Pancreatitis, IPMN
Sponsor: Medical University of Graz

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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                                                                                    Protocol 
 
 
 
 
 
    Evaluation of the diagnostic value of TOF-18F-FDG PET/CT 
               in patients with suspected pancreatic cancer 
 
 
 
 
 
                                                                                       September 2013 
 
 Content 
 
 
 
 
 Summary……………………………………………………………………………………………………………………………………….. 
2 
 Background information…………………………………………………………………………………………………………………. 
4 
 Study hypothesis…………………………………………………………………………………………………………………………….. 
6 
 Aim of the study……………………………………………………………………………………………………………………………… 
6 
 Study process…………………………………………………………………………………………………………………………………. 
7 
 Patients…………………………………………………………………………………………………………………………………………..  8 
 Patient recruitment……………………………………………………………………………………………………………………….. 
8 
 Protocol: PET/CT……………………………………………………………………………………………………………………………. 
9 
 Data handling…………………………………………………………………………………………………………………………………. 
10 
 References…………………………………………………………………………………………………………………………………….. 
11 
 
 
 
 
 
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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Summary 
 
According to the application for the responsible ethics committee of the Medical University of Graz 
a study is to be performed for the „evaluation of the diagnostic value of TOF-18F-FDG PET/CT in 
patients with suspected pancreatic cancer“. 
 
The essential idea of the study is the analysis of the use of early (30min p.i.) and delayed (90min p.i) 
imaging as well as a diagnostic CT of the abdomen with contrast medium and pancreas protocol for 
characterization of pancreatic masses with TOF (Time-of-Flight)-18F-FDG-PET/CT. 
 
According to current scientific evidence, there are no studies in the literature regarding the 
characterization of pancreatic masses by the "Time-of-Flight"-technique (TOF) within PET/CT. 
Usually, the differentiation between chronic pancreatitis and pancreatic carcinoma is often not possible. 
Likewise, the differentiation of the pancreas from surrounding anatomical structures (duodenum) in 
PET/CT with low dose CT is often not possible. An exact diagnosis of a possible malignancy or 
benignancy, as well as the precise anatomical localization of the detected lesion, is however of decisive 
importance for the further therapeutic procedure [1-4]. If a benign lesion is present, an extensive 
operation (Whipple operation) may not be necessary.  
 
As a rule, patients with suspected pancreatic cancer are assigned to the Division of Nuclear Medicine 
for 18F-FDG PET-CT imaging. Early (30min p.i.) and delayed images (90min p.i.) are taken to better 
distinguish between malignant from inflammatory lesions. After the PET/CT examination, a TOF-
reconstruction is performed, which does not require the presence of the patient, but improves the image 
quality to differentiate the lesion in the pancreas better. For better anatomical demarcation of the 
pancreas of adjacent structures (duodenum) additionally a diagnostic CT of the abdomen (up to the iliac 
crest) with pancreas protocol (2 phases) with i.v. administration of iodine-containing contrast medium 
(Visipaque®) and oral administration of a negative contrast medium (500 ml water) for intestinal 
distension is additionally performed. After consultation with the referring physician, it must be ensured 
for reasons of radiation hygiene that the patients do not have a diagnostic CT with contrast agent before 
the PET/CT examination.  If this is not possible, a diagnostic CT of the upper abdomen (up to the lower 
liver margin) is performed with pancreas protocol with 2 phases (arterial and portal venous). 
In most cases these patients are operated, only in the rarest of cases, a biopsy/brush swab is carried 
out beforehand. The histopathological preparation of the surgical specimen is then performed. These 
steps are routine. This approach is to be retained in the project. These steps are 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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1) Assignment of the patient to the TOF-PET-CT (with images 30min und 90min p.i.) 
2) Performing a diagnostic CT of the abdomen with parenteral and oral contrast media and pancreas   
     protocol as part of the PET/CT examination 
3) Routine performance of the operation/fine needle puncture  
4) Routine histopathological evaluation 
With the help of the enclosed Informed Consent, the patient‘s information and written consent are duly 
given. Furthermore, in the case of administration of parenteral contrast medium, the relevant information 
is routinely provided using a contrast medium information sheet. 
The administration of parenteral contrast media is performed according to the ESUR Guidelines [1]. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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Background information 
 
Several studies dealt with the question of differentiating between benign and malignant processes of the 
pancreas using 18F-FDG PET/CT imaging. However, a reliable statement can currently only be made 
by histopathological assessment (considered the gold standard). For this reason, a priori no conclusion 
can currently be drawn as to the malignancy or benignity of the lesion in question. According to recent 
studies, malignant pancreatic diseases occur in patients with suspected pancreatic carcinoma and 
condition after pancreatoduodenectomy or fine needle aspiration with a frequency of 66-81% (47-78% 
of which are adenocarcinomas), benign diseases with a frequency of 19-34%, of which about 60% are 
inflammatory diseases and 40% benign cystic tumors [2-5].  
In this study, patients with suspected benign diseases that are not operated and do not have a fine 
needle biopsy and are only monitored by radiological follow-ups are excluded.  
 
According to the current status of science, there are no studies in the literature concerning the 
characterization of pancreatic lesion expansions using the "Time-of-Flight"-technique (TOF) in the 
framework of PET/CT. The TOF technique is a new reconstruction algorithm in PET/CT that can only be 
applied to newer devices. High-definition PET technology can significantly improve spatial resolution ( to 
2 mm) and increase sensitivity (TOF) by a factor of 3. The combination of both techniques (HD-PET 
with TOF) is called Ultra HD-PET. 
The 18F-FDG PET/CT is indicated for staging in patients with suspected pancreatic carcinoma and was 
also classified as 1a indication for differentiation between inflammation and pancreatic carcinoma 
according to the 3rd German Interdisciplinary Consensus [6]. In patients with suspected pancreatic 
carcinoma, diagnosis is often only possible with difficulty due to the limited anatomical assignment of 
small focal lesions and discreetly increased tracer-uptake, differentiation between benign and malignant 
is often not possible, i.e., differentiation between chronic pancreatitis and a malignant process is often 
only possible to a minimal extent. According to clinical studies [7;8;21-26], the TOF-technique and 
additional i.v. administration of iodine-containing contrast medium and oral administration of a negative 
contrast medium can significantly improve the sensitivity and anatomical differentiation of the target 
organ from adjacent structures. However, this technique has not yet been used in patients with 
suspected pancreatic cancer.  
Another already established method to better distinguish inflammatory from malignant lesions in 
PET/CT is to take images at two different time points and to compare the Standard Uptake Value 
(SUV), a measure of regional accumulation intensity, at these two times [3;17;18]. Here an increased 
FDG-uptake already in the early images is classified as benign/inflammatory, and an increase in FDG -

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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uptake in the delayed images is classified as malignant. A missing FDG uptake both in the early and the 
delayed images is considered benign.  
The diagnostic procedure of 18F-FDG PET is based in case of oncological questions on the mechanism 
that tumor cells show an increased glucose metabolism and that these areas become visible in nuclear 
medical imaging through increased 18F-FDG tracer uptake. The SUV has established itself as a semi-
quantitative measure of uptake concerning patient weight (SUV/bw), which is used both for staging and 
for determining tumor boundaries [3;9-14;17-20;21;27-31]. For further curative as well as palliative 
treatment, knowledge of the exact tumor boundaries is essential for the further treatment steps. On the 
one hand, these are needed for measurement and differentiation (from vital structures) as well as for 
planning (knowledge of the exact tumor size) in further treatment [32-34]. To date, CT and MRI have 
mainly been used as morphological methods to delimit tumors and to assess the resectability, whereby 
functional imaging often plays a decisive role in therapy decisions but is currently hardly taken into 
account for the problems of delimitation and resectability.  
PET/CT is routinely performed in the suspected case of pancreatic cancer [6-20]. Subsequently, a 
subtotal pancreaticoduodenectomy (Whipple operation) with lymphadenectomy is performed routinely in 
cases of urgent suspicion of malignancy and PET scintigraphically confirmed absence of distant 
metastases. Thereby in addition to the pancreatic head and the duodenum the gall bladder, distal bile 
duct, and gastric antrum are removed. At the University Clinic for Surgery Graz, a previous sonographic 
or CT-controlled biopsy is usually not performed due to the danger of sting canal metastases in the case 
of resectable tumors. If necessary, a diagnostic laparotomy is performed. Even a negative fine needle 
puncture that may have been performed beforehand does not rule out an operation. However, in the 
rare case of a CT-guided biopsy alone without subsequent surgery, such patients should also be 
included in the present study. PET as well as the operation/fine needle puncture are routine clinical 
procedures and are therefore not explained further. 
In the area of pancreatic lesions, it is difficult to distinguish adjacent anatomical structures (duodenum). 
For this reason, in the present study additionally, a parenteral iodine-containing (Visipaque®) and a 
negative oral contrast medium (500 ml water) will be administered. One difficulty of such studies is that 
the dignity of the tumor can only be determined after histopathological examination of the surgical 
specimen.  
 
 
 
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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Study hypothesis 
 
Early- (30min p.i.) and delayed images (90min p.i.), diagnostic CT of the abdomen with contrast medium 
and Time-of-Flight (TOF)-reconstruction within the framework of 18F-FDG PET/CT allow an 
improvement in the differentiation of malignant from benign lesion expansions of the pancreas. 
 
Aim of the study 
 
The aim of the study is to improve the differentiation between malignant and benign lesions in the 
pancreas in patients with suspected pancreatic cancer by images 30min und 90min p.i. and a diagnostic 
CT of the abdomen with contrast medium in the context of TOF-18F-FDG PET/CT and thus to improve 
the quality of PET/CT findings. Also, a cut-off value of SUV will be determined in correlation with the 
histopathological results to better differentiate between malignant and benign lesions of the pancreas. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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evaluation
criteria review
information       
signature of  informed 
consent
TOF-PET/CT examination 
with images 30min and 
90min p.i.
operation/fine needle  
puncture
determination of SUV and 
qualitative image assessment
histopathological preparation
Study process 
                                                                      Legend:  
Assignment with suspected diagnosis                                                                • grey: routine examination 
                                                                                                            • blue: study-specific work steps   
 
 
 
 
 
 
 
                                                                                                                                                                                  
                                                                          
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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Patients 
 
118 patients are to be diagnosed continuously according to protocol. 
 
Inclusion criteria: 
• patients with suspected pancreatic cancer (morphologically suspect)  
• operation/fine needle puncture 
 
PET/CT examination with TOF-reconstuction algorithm and contrast medium: 
• sober 
• plasma glucose level < 140 mg/dl 
• position capability 
• checking of:  • creatinine value < 1.2 mg/dl (for values >1.2 mg/dl  
                       no administration of  contrast medium) and eGFR-value > 45 ml/min/1.73 m²   
                       (for values < 45 ml/min/1.73 m² no administration of contrast medium) 
                     • TSH-value 0.1-4.0 µU/ml (for values <0.1 µU/ml 
                        no administration of contrast medium) 
Exclusion criteria: 
• patients under 18 years 
• plasma glucose level > 140 mg/dl 
• patients with histopathologically confirmed distant metastases at the time of PET/CT examination 
• patients with non-pancreatic tumors 
• patients, who will not undergo surgery or had no fine needle puncture (FNP) and therefore 
have no histopathological findings of the pancreas 
• pregnancy 
 
Patient recruitment 
As a rule, the patients are referred to the Division of Nuclear Medicine for diagnostic staging using 18F-
FDG PET/CT. As part of the preparation of the patients for the PET/CT examination, the principle 
investigator and other staff members will provide the information, and in case of participation at the 
study, the Informed Consent (enclosed) will be signed.  
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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Protocol: PET/CT 
After the patients have been admitted to PET/CT operation/fine needle biopsy must be performed within 
a maximum of 4 weeks. 
 
Patient preparation  
• Blood sugar control < 140 mg/dl 
• Administration of the tracer in the PET application room  
 
 Application 
• Intravenous injection of maximal 370 MBq 18F-FDG (fluorodeoxyglucose) 
           - depending on the body weight (according to EANM European 
           Dose-Card corresponds to approx. 7mSv patient dose) 
 
Patient preparation 
• Rest for 30 minutes (tempered and darkened) while oral administration of 500 ml water (negative 
contrast medium) 
• Immediately before the start of the examination empty the bladder as thoroughly as possible 
• Remove all metallic objects from the test area to avoid artifacts            
• Comfortable supine position of the patient during acquisition  
 
Examination device 
• Siemens Biograph mCT 40 
 
Protocol 
• CT according to 120kV 50mAs eff. (scout, quality standard low dose)  
• Whole body (skull base to thigh): static acquisition of 6 bed-positions (depending on patient size) 
of 2 minutes each (with BMI >30 acquisition time extend by 1 minute per position) 
• 90min p.i. image (abdomen): static image of 2-3 bed-positions (depending on patient size) at 2 
minutes each (with BMI >30 acquisition time extend by 1 minute per position) 
 
 
Image evaluation, SUV-calculation 
• Evaluation station: Siemens SYNGO MMWP 
 
 
Work area 
• University Clinic of Radiology, Division of Nuclear Medicine, room 440/438, 4th floor 
 
 
Protocol diagnostic CT of the abdomen with pancreas protocol and 
contrast medium  
 
Examination device 
• Siemens Biograph mCT 40 
 
Protocol 
• CT according to 120kV 220mAs in spiral mode (according to a standard dose length product of 
approx. 450 resp. 225 mGycm, corresponding to approx. 6.7 mSv patient dose with diagnostic    

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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           CT to the iliac crest or approx. 3.3 mSv with diagnostic CT to the lower liver margin). The dose  
           length products were derived from measurements on the patient and the phantom. 
• Reconstruction to 5mm layer thickness with an increment of Schichtdicke 3 mm 
• i.v.-administration of 1,4 ml/kg body weight (bw) Visipaque® (Iodixanol)  at a rate of 3 ml/s and 
image acquisition over 2 phases (arterial, portal venous) up to the iliac crest/ to the lower liver 
margin with already performed CT of the abdomen with pancreas protocol before at least 2 
weeks  
 
 
Data-handling 
The patient data is encoded with a consecutive number and managed in an Excel spreadsheet. The 
colleagues working on the project make the entries in this table.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

         Evaluation of the diagnostic value of TOF-18F-FDG PET/CT                                                 Protocol version 1.0 
         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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         in patients with suspected pancreatic cancer                                                                          02.09.2013 
                                                                                         
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