TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer

Aim of the prospective study is a better differentiation of benign and malignant lesions in the pancreas in patients with suspected pancreatic cancer using images 30 and 90 min p.i. (post injectionen) and a diagnostic CT (computed tomography) scan of the abdomen within the Time of Flight (TOF)-18F-FDG-PET/CT and thus an improvement of the quality of PET/CT findings.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases IPMN Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In the course of this the procedure follows the necessary steps of routine treatment:

Assignment of the patient with a suspect of pancreatic cancer.
Performing time of flight (TOF)-18F-FDG-PET/CT with images 30 min and 90 min p.i.
Performing a diagnostic CT of the abdomen with parenteral contrast medium and pancreatic protocol (in case of normal creatinine, GFR, and TSH levels) as well as oral contrast medium (in accordance with the ESUR-guidelines) as part of the PET/CT examination.
Routine performance of the operation /fine needle puncture/biopsy
Routine histopathological evaluation of the surgical specimen/biopsy

For this study, a diagnostic CT of the abdomen with contrast medium (intravenous as well as oral) and with pancreatic protocol and without parenteral contrast medium in case of elevated creatinine or decreased TSH (thyroid-stimulating hormone) or GFR (glomerular filtration rate) levels is performed additionally within the routinely performed PET/CT for better differentiation of the target organ from adjacent structures. Furthermore, early (30 min p.i.) and delayed (90 min p.i.) images and a TOF-reconstruction following the PET/CT examination (without patient contact) should be performed for better differentiation between inflammatory and malignant lesions of the pancreas. The regional tracer-uptake should now be measured quantitatively by SUV (Standard Uptake Value) in the TOF-PET/CT images over the FDG-accumulating lesions in the pancreas at those two times. In case of an increased FDG-uptake in the early images, the lesion will be assessed as benign/inflammatory and with an increase of the FDG-uptake in the delayed images as malignant. No FDG-uptake in the early as well as in the delayed images will be classified as benign. As a reference standard, the histopathological diagnosis is used. Subsequently, a cut-off value of the SUV should be determined by ROC-analysis.

According to current scientific evidence regarding the characterization of pancreatic masses by means of "Time of Flight"(TOF)-technique, there are no studies in the literature.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients with suspected pancreatic cancer

Exclusion criteria

persons under 18 years of age
patients with blood glucose level ≥160 mg/dl at the time of the PET/CT examination
patients who will not be operated or biopsied and in which thus there are no histopathological findings of the pancreas
pregnant women

Treatment and study plan

PET/CT results with TOF/without TOF

Diagnostic Test

Diagnostic CT of the abdomen or upper abdomen with parenteral contrast medium (Visipaque=Iodixanol) if creatinine, GFR, and TSH levels are within the normal range and oral (water) contrast medium within TOF-18F-FDG PET/CT. In the case of elevated creatine or decreased GFR or TSH levels a diagnostic CT of the abdomen or upper abdomen without contrast medium is performed.

Biopsy or FNA or operation of the pancreas.

Primary outcomes

SUVmax (Maximal Standard Uptake Value) Measurement 30 and 90 Min p.i. (Post Injection)

Time frame: 2 hours

Quantitative measurement of regional tracer uptake by SUVmax in the TOF-PET/CT and standard PET/CT images over the FDG-accumulating lesions in the pancreas 30 and 90min p.i. The histopathological findings (malignant or benign) were assigned to the corresponding SUVmax values of the pancreatic lesions for the calculation of AUC values in ROC analysis. Then AUC values with and without TOF were compared with the DeLong-test to analyze if there is a significant difference in characterization of pancreatic lesions with TOF.
Participants With Increased Tracer Uptake Over the Pancreatic Lesion With and Without TOF

Time frame: 2 hours

The number of participants with increased tracer uptake over the pancreatic lesion, i.e. the number of pancreatic lesions with increased tracer uptake with and without TOF. One pancreatic lesion per patient was measured.

Secondary outcomes

Lesion Size

Time frame: 2 hours

Lesion or tumor size in cm in the pancreas measured in the diagnostic CT of the abdomen or upper abdomen.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Evaluation of the Diagnostic Value of TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer

Acronym: TOF-P

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Apr 16, 2019
Registry last updated: May 29, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed