Low Grade GliomaPET-FETIINCT02286531
Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine, a New Tracer PET, in the Diagnosis of Low Grade Glioma
A study testing O-(2[18F]FLUOROETHYL)-L-TYROSINE in people with Low Grade Glioma, run by University Hospital, Toulouse at 3 sites in France.
Trial summary
Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II (referring to the current diagnostic gold standard represented by the histopathology exam of a tumor sample). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Glioma
- What is being tested?
- O-(2[18F]FLUOROETHYL)-L-TYROSINE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2010to Dec 2014
- 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
- Patients over 18 years
- Diagnosis of glioma grade II referred on clinical and MRI morphologic
- Realization of a brain MRI in preoperative condition of neuronavigation (MRI sequences including axial T2, Flair, T1, T1 with gadolinium) in a within 1 month with FET PET.
- Histological examination scheduled within one month with FET PET by resection (complete or partial) or by biopsy
- Patients who signed informed consent
- No against-indication for PET
- No against-indications to MRI
Who cannot join
- Grade II glioma who have received specific treatment with radiotherapy and or chemotherapy.
- Pregnant or breastfeeding women.
- Weight greater than 120 Kg
- against-indication to PET
- against- indication gadolinium
- Possible side effects to MRI (magnetic foreign bodies, pacemaker, congestive severe renal).)
- Patient under guardianship
- No coverage by social security
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de CAEN
Caen, 14033
Hôpital de la Pitié Salpétrière
Paris
UHToulouse
Toulouse, 31000
About this study
Official title: Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine (or FET), a New Tracer PET (Positron Emission Tomography) , in the Diagnosis of Low Grade Glioma
Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II (referring to the current diagnostic gold standard represented by the histopathology exam of a tumor sample).
Read the detailed description
Low-grade glioma is a malignant tumor of young adults (12.5% of gliomas, incidence of 0.99 / 100,000). Median survival, linked to anaplastic transformation is estimated between 7 and 10 years, with great individual variability in the rate of evolution. The morphological MRI, standard assessment tool at present, suffers from many limitations, especially concerning the positive diagnosis, the targeting of surgical biopsies and tumor delineation which is essential to treatment The study design is a validation study of a new diagnostic procedure. This study is prospective, no randomized, multicenter involving 10 centers (Toulouse University Hospital, Caen, Tours, AP-HP Pitie Salpetriere, Lille, Angers, Rennes, Nîmes, Nantes and Nancy). Will be eligible patients in whom the diagnosis of grade II glioma is suspected according to clinical data and MRI, after evaluation and multidisciplinary meeting at which histological confirmation is scheduled within a maximum period of one month.
FET PET scans will be performed before any procedure or surgical treatment and the data will be merged with MRI. The gold standard is histological examination or biopsy material, or complete resection of the tumor. A minimum of three biopsies per patient will be realized. The pathologist will not see the results of PET-FET 100 patients will be enrolled over a period of 5 years. The area under the curve will be determined on a non-parametric for each increase in the value of PET-FET at near 10th. The sensitivities, specificities, positive predictive values will be estimated with confidence intervals at 95%. Factors to be considered in the analysis, the intrasubject variability related to the fact that several positive and negative results are found for each subject included. The concordance between the data-FET PET and MRI will be sought.
The expected benefits are a better diagnostic ability of PET-FET which results in a specific targeting of biopsies with fewer tests to false negatives and false positives, thus a better diagnostic yield of this invasive procedure. Furthermore, the characteristics of this test applied to all of the tumor may help to better define the limit between healthy and tumor areas and thus reduce the radiation fields to the volumes strictly necessary. These volumes are currently defined on the results of the only morphological MRI and can be further clarified
- Conditions
- Low Grade Glioma
- Being tested
- O-(2[18F]FLUOROETHYL)-L-TYROSINE
- Keywords
- : Low grade glioma, PET, FET, MRI, Standardized uptake value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-(2[18F]FLUOROETHYL)-L-TYROSINEDrug
Also called FET imaging
Patient 0.1 mCi / kg (maximum 185 MBq) of FET will be injected through the venous catheter. At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| FET imaging | Experimental | FET Imaging. Patient 0.1 mCi / kg (maximum 185 MBq) of FET with 'O-(2[18F]FLUOROETHYL)-L-TYROSINE' will be injected through the venous catheter. At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes) Receives: Drug: O-(2[18F]FLUOROETHYL)-L-TYROSINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the overall discriminating capacity of FET-PET in the diagnosis of glioma grade II (referring to current diagnostic gold standard represented by the histopathological examination of a tumor sample).
Measured: TEP and MRI Imagy 1 month before surgery
Secondary outcomes (3)
- Determine the threshold with the highest positive likelihood ratio. - Determine the threshold with the highest positive likelihood ratio.
Measured: 1 month before surgery
Assess the concordance of the data-FET PET and MRI morphological data reported to histological diagnostic
Measured: 1 month before surgery
Evaluate the positive and negative predictive value of this threshold in order to improve the delineation of the tumor area
Measured: 1 month before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJun 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade GliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Payoux, MD PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286531
- Sponsor's protocol ID
- 08 111 01
- Acronym
- PET-FETII
- Status last verified
- Aug 2015
- First submitted
- 4 Nov 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine (or FET), a New Tracer PET (Positron Emission Tomography) , in the Diagnosis of Low Grade Glioma
- ClinicalTrials.gov ID
- NCT02286531
- Acronym / sponsor ID
- PET-FETII / 08 111 01
- Conditions
- Low Grade Glioma
- Keywords
- : Low grade glioma, PET, FET, MRI, Standardized uptake value
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Nov 2014 (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.
Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II (referring to the current diagnostic gold standard represented by the histopathology exam of a tumor sample).
Detailed description
Low-grade glioma is a malignant tumor of young adults (12.5% of gliomas, incidence of 0.99 / 100,000). Median survival, linked to anaplastic transformation is estimated between 7 and 10 years, with great individual variability in the rate of evolution. The morphological MRI, standard assessment tool at present, suffers from many limitations, especially concerning the positive diagnosis, the targeting of surgical biopsies and tumor delineation which is essential to treatment The study design is a validation study of a new diagnostic procedure. This study is prospective, no randomized, multicenter involving 10 centers (Toulouse University Hospital, Caen, Tours, AP-HP Pitie Salpetriere, Lille, Angers, Rennes, Nîmes, Nantes and Nancy). Will be eligible patients in whom the diagnosis of grade II glioma is suspected according to clinical data and MRI, after evaluation and multidisciplinary meeting at which histological confirmation is scheduled within a maximum period of one month.
FET PET scans will be performed before any procedure or surgical treatment and the data will be merged with MRI. The gold standard is histological examination or biopsy material, or complete resection of the tumor. A minimum of three biopsies per patient will be realized. The pathologist will not see the results of PET-FET 100 patients will be enrolled over a period of 5 years. The area under the curve will be determined on a non-parametric for each increase in the value of PET-FET at near 10th. The sensitivities, specificities, positive predictive values will be estimated with confidence intervals at 95%. Factors to be considered in the analysis, the intrasubject variability related to the fact that several positive and negative results are found for each subject included. The concordance between the data-FET PET and MRI will be sought.
The expected benefits are a better diagnostic ability of PET-FET which results in a specific targeting of biopsies with fewer tests to false negatives and false positives, thus a better diagnostic yield of this invasive procedure. Furthermore, the characteristics of this test applied to all of the tumor may help to better define the limit between healthy and tumor areas and thus reduce the radiation fields to the volumes strictly necessary. These volumes are currently defined on the results of the only morphological MRI and can be further clarified
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FET imaging | Experimental | Drug: O-(2[18F]FLUOROETHYL)-L-TYROSINEFET Imaging. Patient 0.1 mCi / kg (maximum 185 MBq) of FET with 'O-(2[18F]FLUOROETHYL)-L-TYROSINE' will be injected through the venous catheter. At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years
- Diagnosis of glioma grade II referred on clinical and MRI morphologic
- Realization of a brain MRI in preoperative condition of neuronavigation (MRI sequences including axial T2, Flair, T1, T1 with gadolinium) in a within 1 month with FET PET.
- Histological examination scheduled within one month with FET PET by resection (complete or partial) or by biopsy
- Patients who signed informed consent
Key exclusion criteria (8 listed)
- Grade II glioma who have received specific treatment with radiotherapy and or chemotherapy.
- Pregnant or breastfeeding women.
- Weight greater than 120 Kg
- against-indication to PET
- against- indication gadolinium
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 |
|---|---|---|
| O-(2[18F]FLUOROETHYL)-L-TYROSINEAlso: FET imagingPatient 0.1 mCi / kg (maximum 185 MBq) of FET will be injected through the venous catheter. At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes) | Drug | FET imaging |
Primary outcome
Determine the overall discriminating capacity of FET-PET in the diagnosis of glioma grade II (referring to current diagnostic gold standard represented by the histopathological examination of a tumor sample).
Time frame: TEP and MRI Imagy 1 month before surgery
3 secondary outcomes
- Determine the threshold with the highest positive likelihood ratio. - Determine the threshold with the highest positive likelihood ratio.
Time frame: 1 month before surgery
Assess the concordance of the data-FET PET and MRI morphological data reported to histological diagnostic
Time frame: 1 month before surgery
Evaluate the positive and negative predictive value of this threshold in order to improve the delineation of the tumor area
Time frame: 1 month before surgery
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 19 Aug 2015.
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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.
Pierre Payoux, MD PHD principal investigator
University Hospital, Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O-(2[18F]FLUOROETHYL)-L-TYROSINE in people with Low Grade Glioma, run by University Hospital, Toulouse at 3 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 7 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Determine the overall discriminating capacity of FET-PET in the diagnosis of glioma grade II (referring to current diagnostic gold standard represented by the histopathological examination of a tumor sample). (time frame: TEP and MRI Imagy 1 month before surgery). 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 19 Aug 2015.