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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT results with TOF/without TOF | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Stanzel, MD | Medical University of Graz | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23278193 | Background | 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. | |
| 23580090 |
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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.
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Of 174 enrolled participants, 120 participants met ALL inclusion criteria having TOF-18F-FDG PET/CT with diagnostic CT of the abdomen or upper abdomen AND biopsy or FNA or operation of the pancreas and were analyzed. Participants not completing the study were excluded and therefore not analyzed (54 participants).
Participants were recruited based on physician referral at one university hospital between February 2014 and January 2019. The first participant was enrolled on February 7, 2014, and the last participant was enrolled in January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | PET/CT Results With TOF/Without TOF | Participants received TOF-18F-FDG PET/CT 30 and 90min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen < 2 weeks ago) with contrast medium in the case of normal creatinine, GFR, and TSH levels (101 participants). In the case of elevated creatinine or decreased GFR or TSH levels a diagnostic CT without contrast medium was performed (19 participants). After PET/CT examination the participants received a biopsy or FNA (fine-needle aspiration) or operation of the pancreas. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants with biopsy or FNA or operation of the pancreas.
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| ID | Title | Description |
|---|---|---|
| BG000 | PET/CT Results With TOF/Without TOF | Participants received TOF-18F-FDG PET/CT 30 and 90 min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen < 2 weeks ago) with contrast medium in case of normal creatinine, GFR, and TSH levels. In the case of elevated creatinine and decreased GFR and TSH levels a diagnostic CT without contrast medium was performed. After PET/CT examination participants received biopsy or FNA or operation of the pancreas. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 120 participants meeting ALL inclusion criteria, i.e. completed TOF-18F-FDG PET/CT AND biopsy or FNA or operation were analyzed. 54 participants had TOF-18F-FDG PET/CT but no biopsy or FNA or operation or the tumor was not in the pancreas and were therefore excluded from the study. | Posted | Number | SUVmax | 2 hours |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PET/CT Results With TOF/ Without TOF | 101 participants received diagnostic CT of the abdomen/upper abdomen with contrast medium within the PET/CT examination and 19 participants had diagnostic CT of the abdomen or upper abdomen without contrast medium due to elevated creatine or decreased GFR (glomerular filtration rate) or TSH (thyroid-stimulating hormone) levels. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotensive shock | Cardiac disorders | ESUR guidelines | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe vomiting | Gastrointestinal disorders | ESUR guidelines | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susanne Stanzel | Medical University of Graz, Department of Radiology, Division of Nuclear Medicine | +43-316-385-81789 | susanne.stanzel@medunigraz.at |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2018 | Apr 1, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 2, 2013 | Apr 9, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2019 | Apr 9, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Prospective study with one single group with two kinds of PET/CT imaging (with TOF-reconstruction and without TOF-reconstruction) for each patient.
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All parties involved in the clinical trial have knowledge of the interventions assigned to the individual participants.
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|
| 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. |
| 21866433 | Result | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Type of pancreatic mass | Count of Participants | Participants |
|
| History of pancreatitis | Count of Participants | Participants |
|
| Dignity of pancreatic lesions | Count of Participants | Participants |
|
| Pathological diagnoses of malignant pancreatic lesions | 85 of 120 participants had malignant pancreatic lesions. | Count of Participants | Participants |
|
| Pathological diagnoses of benign pancreatic lesions | 35 of 120 participants had benign pancreatic lesions. | Count of Participants | Participants |
|
SUVmax values of the pancreatic lesions with TOF 30min p.i. |
| OG001 | SUVmax Without TOF 30min p.i. | SUVmax values of the pancreatic lesions without TOF 30min p.i. |
| OG002 | SUVmax TOF 90min p.i. | SUVmax values of the pancreatic lesions with TOF 90min p.i. |
| OG003 | SUVmax Without TOF 90min p.i. | SUVmax values of the pancreatic lesions without TOF 90min p.i. |
|
|
|
| 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. | 120 participants meeting ALL inclusion criteria, i.e. completed TOF-18F-FDG PET/CT AND biopsy or FNA or operation were analyzed. 54 participants had TOF-18F-FDG PET/CT but no biopsy or FNA or operation or the tumor was not in the pancreas and were therefore excluded from the study. | Posted | Count of Participants | Participants | 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. | 120 participants meeting ALL inclusion criteria, i.e. completed TOF-18F-FDG PET/CT AND biopsy or FNA or operation were analyzed. 54 participants had TOF-18F-FDG PET/CT but no biopsy or FNA or operation or the tumor was not in the pancreas and were therefore excluded from the study. | Posted | Mean | Standard Deviation | cm | 2 hours |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| Cardiac arrest | Cardiac disorders | ESUR guidelines | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | ESUR guidelines | Systematic Assessment |
|
| Convulsion | Nervous system disorders | ESUR guidelines | Systematic Assessment |
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| Nausea, mild vomiting | Gastrointestinal disorders | ESUR guidelines | Systematic Assessment |
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| Marked urticaria | Skin and subcutaneous tissue disorders | ESUR guidelines | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | ESUR guidelines | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | ESUR guidelines | Systematic Assessment |
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| Facial edema | Skin and subcutaneous tissue disorders | ESUR guidelines | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | ESUR guidelines | Systematic Assessment |
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| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | ESUR guidelines | Systematic Assessment |
|
| Vasovagal attack | Nervous system disorders | ESUR guidelines | Systematic Assessment |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |