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2014-02-07
2019-01-17
2019-03-05
174
NCT03914950
Medical University of Graz
Medical University of Graz
INTERVENTIONAL
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.
In the course of this the procedure follows the necessary steps of routine treatment: 1. Assignment of the patient with a suspect of pancreatic cancer. 2. Performing time of flight (TOF)-18F-FDG-PET/CT with images 30 min and 90 min p.i. 3. 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. 4. Routine performance of the operation /fine needle puncture/biopsy 5. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-04-02 | 2020-03-30 | 2020-05-14 |
2019-04-11 | 2020-04-29 | 2020-05-29 |
2019-04-16 | 2020-05-13 | 2020-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: PET/CT results with TOF/without TOF * Diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen < 2 weeks ago) with 2 phases, 1 - 4 mSv, ca. 20 sec., 1 x * Contrast medium (Iodixanol 550 mg/ml) 1 x 1.4 ml/kg body weight i.v. for 40 sec, 1 x if | DIAGNOSTIC_TEST: PET/CT results with TOF/without TOF
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| SUVmax (Maximal Standard Uptake Value) Measurement 30 and 90 Min p.i. (Post Injection) | 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. | 2 hours |
| Participants With Increased Tracer Uptake Over the Pancreatic Lesion With and Without TOF | 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. | 2 hours |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Lesion Size | Lesion or tumor size in cm in the pancreas measured in the diagnostic CT of the abdomen or upper abdomen. | 2 hours |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
