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

May 14, 2020 updated by: Medical University of Graz

Evaluation of the Diagnostic Value of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • 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 creatinine, GFR, and TSH levels are within the normal range
  • 1 x 500 ml water oral, 1 x
  • Biopsy or FNA (fine-needle aspiration) or operation of the pancreas
Diagnostic test: PET/CT results with TOF/without TOF

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours
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.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Susanne Stanzel, MD, Medical University of Graz, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (ACTUAL)

February 7, 2014

Primary Completion (ACTUAL)

January 17, 2019

Study Completion (ACTUAL)

March 5, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protokoll TOF-P V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data (IPD) will be available apart from the principle investigator only to the statistician who carries out the statistical evaluation of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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