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

NCT03914950 | Completed Results

• 1 other identifier: Protokoll TOF-P V1
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pancreatic Cancer; Pancreatitis; IPMN

Keywords

TOF-18F-FDG PET/CT; pancreatic lesions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Lesion Size

  2 hours

Study Arms (1)

PET/CT results with TOF/without TOF

OTHER

* 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

Interventions

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.

PET/CT results with TOF/without TOF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with suspected pancreatic cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Related Publications (3)

• 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.

  PMID: 23278193 BACKGROUND

• 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.

  PMID: 23580090 BACKGROUND

• Stacul F, van der Molen AJ, Reimer P, Webb JA, Thomsen HS, Morcos SK, Almen 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 Contrast Media Safety Committee guidelines. Eur Radiol. 2011 Dec;21(12):2527-41. doi: 10.1007/s00330-011-2225-0. Epub 2011 Aug 25.

  PMID: 21866433 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

The actual discontinuation rate was higher than expected/anticipated. Therefore, the analysis of the primary outcome measure, a difference between AUC values with and without TOF in ROC-analysis, was underpowered.

Results Point of Contact

• Title: Dr. Susanne Stanzel
• Organization: Medical University of Graz, Department of Radiology, Division of Nuclear Medicine

susanne.stanzel@medunigraz.at

+43-316-385-81789

Study Officials

• Susanne Stanzel, MD

  Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All parties involved in the clinical trial have knowledge of the interventions assigned to the individual participants.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study with one single group with two kinds of PET/CT imaging (with TOF-reconstruction and without TOF-reconstruction) for each patient.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 16, 2019
• Study Start: February 7, 2014
• Primary Completion: January 17, 2019
• Study Completion: March 5, 2019
• Last Updated: May 29, 2020
• Results First Posted: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share