TumorNCT01485679
18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas
A study testing 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography in people with Tumor, run by Nantes University Hospital at 12 sites in France.
Trial summary
The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 12 sitesFrance
- Study dates
- Jan 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults with age equal or above 18
- Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
- if woman being of childbearing potential, woman taking contraceptive measures
- Patient able to understand benefits and risks of protocol
- Subject affiliated to French health insurance (Social Security)
- Informed consent form signed
Who cannot join
- Patients not fulfilling inclusion criteria
- Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
- Chemotherapy within 2 the months preceding the TEP-CT
- Acute pancreatitis within 2 the months preceding the TEP-CT
- Pregnant women or breast-feeding women refusing to temporary stop it
- Diabetes not equilibrated (checked by glycemia and glycosylated hemoglobin (HbA1c) at inclusion) or Fasting blood glucose below 7mmol/L (126 g/L before the TEP)
- Patients with claustrophobia
- Patients not accepted under the anesthesia point of view
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU Nord
Amiens, France, 80080
Maison de Haut Lévêque CHU
Bordeaux, France, 33604
Hôpital Beaujon APHP
Clichy, France, 92110
Hôpital C Huriez
Lille, France, 59037
Hospices Civils de Lyon
Lyon, France, 69437
Institut Paoli Calmettes
Marseille, France, 13273
CHU Nord
Marseille, France, 13915
CHU
Nantes, France, 44093
Hôpital St-Antoine
Paris, 75012
CHU Hôpital Pontchaillou
Rennes, France, 35033
Hôpital de Hautepierre
Strasbourg, France, 67098
CHU Rangueil
Toulouse, 31059
About this study
Official title: Evaluation of 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas
The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.
Read the detailed description
Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.
- Conditions
- Tumor
- Being tested
- 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
- Keywords
- 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,, Patients with intraductal papillary mucinous tumor of the pancreas, intraductal papillary mucinous, pancreas
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomographyOther
18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
| Study group | Role | What they receive |
|---|---|---|
| positrons emission tomography | Experimental | Not described Receives: Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.
TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas.
The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma".
Results will then be compared in term of specificity.
Measured: 3 months
Secondary outcomes (3)
Sensitivity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.
TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas.
The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma".
Results will then be compared in term of sensitivity.
Measured: 3 months
Comparison of specificity of the TEP-CT to detect malignant lesions in pancreas versus specificity of conventional devices, the gold standard being the anatomopathological analysis results
Result of conventional devices (such as computed tomography, magnetic resonance cholangiopancreatography or endoscopic ultrasound) will be considered positive if diagnosis is "malignant lesion" or "probable malignant lesion". The 5 parts of the pancreas will be examined.
Measured: 3 months
Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485679
- Sponsor's protocol ID
- BRD/10/06-P
- Status last verified
- Oct 2015
- First submitted
- 26 Aug 2011
- Last updated
- 18 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 18 Fluoro-deoxy-glucose Positrons Emission Tomography Combined With Computed Tomography (18-FDG TEP-CT ) in the Diagnosis of the Degeneration of Intraductal Papillary Mucinous Tumor of the Pancreas
- ClinicalTrials.gov ID
- NCT01485679
- Acronym / sponsor ID
- BRD/10/06-P
- Conditions
- Tumor
- Keywords
- 18 fluoro deoxy glucose positrons emission tomography combined with computed tomography,, Patients with intraductal papillary mucinous tumor of the pancreas, intraductal papillary mucinous, pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate whether the TEP-CT can be sensitive and specific in identifying degenerated intraductal papillary mucinous tumor of the pancreas.The results will be compared to those obtained by the pathological analysis of the removed piece of pancreas.
Detailed description
Before surgery is undertaken, a 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography (18-FDG TEP-CT ) will be performed. The primary outcome of this study is to compare results of the TEP-CT with those obtained by the pathological analysis of the removed piece of pancreas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| positrons emission tomography | Experimental | Other: 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults with age equal or above 18
- Patients diagnosed with intraductal papillary mucinous tumor with surgical indication and for whom it will be possible to have the pathological analysis of the removed piece of pancreas.
- if woman being of childbearing potential, woman taking contraceptive measures
- Patient able to understand benefits and risks of protocol
- Subject affiliated to French health insurance (Social Security)
Key exclusion criteria (8 listed)
- Patients not fulfilling inclusion criteria
- Pancreatic surgery or radiotherapy in the pancreatic zone within 4 the months preceding the TEP-CT
- Chemotherapy within 2 the months preceding the TEP-CT
- Acute pancreatitis within 2 the months preceding the TEP-CT
- Pregnant women or breast-feeding women refusing to temporary stop it
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 |
|---|---|---|
| 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography | Other | positrons emission tomography |
Primary outcome
Specificity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.
Time frame: 3 months
TEP-CT of the different 5 parts of the pancreas (head, uncus, isthmi, body and tail) will be interpreted by nuclearity Doctors. TEP-CT will be considered positive if there is a pathological fixation of the 18-FDG , defined as any focal or diffuse fixation of 18-FDG above the background level of fixation in the pancreas. The anatomopathological analysis of the piece of pancreas removed during the ablative surgery will be considered as positive if the degree of dysplasia seen for each part of the pancreas is "infiltrating carcinoma". Results will then be compared in term of specificity.
3 secondary outcomes
Sensitivity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery.
Time frame: 3 months
Comparison of specificity of the TEP-CT to detect malignant lesions in pancreas versus specificity of conventional devices, the gold standard being the anatomopathological analysis results
Time frame: 3 months
Number of patients for which metastasis will be detected through TEP-CT and confirmed by biopsy and/or conventional specific device
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography in people with Tumor, run by Nantes University Hospital at 12 sites in France.
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 6 inclusion and 8 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Specificity of TEP-CT to point out malignant lesions in pancreas, the gold standard being the anatomopathological analysis of the piece of pancreas removed during the surgery. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2016.