Clinical trial · Interventional

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

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

NCT03914950CI-TRIAL-00045318TOF-PcompletedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
IPMN	—	UNRESOLVED	—
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92
Pancreatitis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
PET/CT results with TOF/without TOF	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
OTHER
label
PET/CT results with TOF/without TOF
description
* 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
interventionNames
1. Diagnostic Test: PET/CT results with TOF/without TOF

Primary outcomes (2)

measure
SUVmax (Maximal Standard Uptake Value) Measurement 30 and 90 Min p.i. (Post Injection)
timeFrame
2 hours
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

BACKGROUNDSanthosh 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
BACKGROUNDNagamachi 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
RESULTStacul 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