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

Pancreatic Cancer Clinical Trial

— TOF-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914950
• Other study ID #: Protokoll TOF-P V1
• Status: Completed
• Phase: N/A
• Start date: February 7, 2014
• Est. completion date: March 5, 2019

Study information

• Verified date: May 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 5, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IPMN
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

References & Publications (3)

Nagamachi S, Nishii R, Wakamatsu H, Mizutani Y, Kiyohara S, Fujita S, Futami S, Sakae T, Furukoji E, Tamura S, Arita H, Chijiiwa K, Kawai K. The usefulness of (18)F-FDG PET/MRI fusion image in diagnosing pancreatic tumor: comparison with (18)F-FDG PET/CT. Ann Nucl Med. 2013 Jul;27(6):554-63. doi: 10.1007/s12149-013-0719-3. Epub 2013 Apr 12. — View Citation

Santhosh S, Mittal BR, Bhasin D, Srinivasan R, Rana S, Das A, Nada R, Bhattacharya A, Gupta R, Kapoor R. Role of (18)F-fluorodeoxyglucose positron emission tomography/computed tomography in the characterization of pancreatic masses: experience from tropics. J Gastroenterol Hepatol. 2013 Feb;28(2):255-61. doi: 10.1111/jgh.12068. — View Citation

Stacul F, van der Molen AJ, Reimer P, Webb JA, Thomsen HS, Morcos SK, Almén T, Aspelin P, Bellin MF, Clement O, Heinz-Peer G; Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR). Contrast induced nephropathy: updated ESUR Co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Lesion Size	Lesion or tumor size in cm in the pancreas measured in the diagnostic CT of the abdomen or upper abdomen.	2 hours