Pancreatic CancerTOF-PNCT03914950
TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer
A study testing PET/CT results with TOF/without TOF in people with Pancreatic Cancer and Pancreatitis, run by Medical University of Graz.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatitis, IPMN
- What is being tested?
- PET/CT results with TOF/without TOF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 7 Feb 2014to 5 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with suspected pancreatic cancer
Who cannot join
- 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
About this study
Official title: 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.
Read the detailed description
In the course of this the procedure follows the necessary steps of routine treatment:
- Assignment of the patient with a suspect of pancreatic cancer.
- Performing time of flight (TOF)-18F-FDG-PET/CT with images 30 min and 90 min p.i.
- 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.
- Routine performance of the operation /fine needle puncture/biopsy
- 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.
- Conditions
- Pancreatic Cancer, Pancreatitis, IPMN
- Being tested
- PET/CT results with TOF/without TOF
- Keywords
- TOF-18F-FDG PET/CT, pancreatic lesions
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT results with TOF/without TOFDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: PET/CT results with TOF/without TOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours
Secondary outcomes (1)
Lesion Size
Lesion or tumor size in cm in the pancreas measured in the diagnostic CT of the abdomen or upper abdomen.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start7 Feb 2014
- Primary completion17 Jan 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study with one single group with two kinds of PET/CT imaging (with TOF-reconstruction and without TOF-reconstruction) for each patient.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Stanzel, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914950
- Sponsor's protocol ID
- Protokoll TOF-P V1
- Acronym
- TOF-P
- Status last verified
- May 2020
- First submitted
- 2 Apr 2019
- Last updated
- 29 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23278193Nagamachi 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.
PubMed 23580090Stacul 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.
PubMed 21866433
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Value of TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03914950
- Acronym / sponsor ID
- TOF-P / Protokoll TOF-P V1
- Conditions
- Pancreatic Cancer, Pancreatitis, IPMN
- Keywords
- TOF-18F-FDG PET/CT, pancreatic lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 7 Feb 2014 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 13 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the course of this the procedure follows the necessary steps of routine treatment:
- Assignment of the patient with a suspect of pancreatic cancer.
- Performing time of flight (TOF)-18F-FDG-PET/CT with images 30 min and 90 min p.i.
- 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.
- Routine performance of the operation /fine needle puncture/biopsy
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study with one single group with two kinds of PET/CT imaging (with TOF-reconstruction and without TOF-reconstruction) for each patient.
| Arm | Type | Receives |
|---|---|---|
| PET/CT results with TOF/without TOF | Other | Diagnostic Test: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with suspected pancreatic cancer
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT results with TOF/without TOFDiagnostic 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. | Diagnostic test | PET/CT results with TOF/without TOF |
Primary outcome
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.
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.
1 secondary outcome
Lesion Size
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23278193Santhosh 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.
- Background: PubMed 23580090Nagamachi 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.
- Results publication: PubMed 21866433Stacul 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Stanzel, MD principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT results with TOF/without TOF in people with Pancreatic Cancer and Pancreatitis, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (Maximal Standard Uptake Value) Measurement 30 and 90 Min p.i. (Post Injection) (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914950, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.