GlioblastomaTIGRENCT03739333
Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.
A study testing 11C-Methionine PET-MRI in people with Glioblastoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- 11C-Methionine PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2019to 26 Jan 2025
- 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 aged 18 or over,
- Patient with glioblastoma treated by radiochemotherapy with temozolomide,
- Patient with suspicion of pseudoprogression between the 1st and 12th month after the end of concomitant chemoradiotherapy,
- Patient receiving a social security scheme,
- Patient for whom informed and written consent to participate has been obtained,
Who cannot join
- Subject under safeguard of justice (tutelage, curatorship),
- Minor patient,
- Patient without signs of progression MRI (stable disease or good response to treatment according to the RANO 2010 criteria),
- Clinical or radiological progression justifying a change of treatment,
- Patient not able to decide and with refusal of the family entitled to continue research.
- Pregnant woman, breastfeeding or old enough to have children but without effective contraception,
- Contraindication to performing an MRI: permanently fixed metal parts (pacemaker, cerebral clip, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia,
- Contraindication to gadolinium according to ANSM 2017 recommendations
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopices Civils de Lyon
Bron, 69 677
DUCRAY François, MD, 00 (33) 4 72 68 13 21, francois.ducray@chu-lyon.fr
ISAL Sibel, MD, 00 (33) 4 72 35 76 29, sibel.isal@chu-lyon.fr
About this study
Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma.
Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis.
The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).
- Conditions
- Glioblastoma
- Being tested
- 11C-Methionine PET-MRI
- Keywords
- glioblastoma, 11C-Methionine PET-MRI, sensitivity, temozolomide, radiotherapy
- Medical subject headings
- Glioblastoma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-Methionine PET-MRIOther
Implementation 11C-Methionine PET-MRI performed for each patient in one place (department of nuclear medicine of Hospices Civils de Lyon). The 11C-Methionine PET-MRI will be performed after radiochemotherapy in patients with MRI suspicious of pseudoprogression.
| Study group | Role | What they receive |
|---|---|---|
| patients with glioblastoma | Experimental | implementation of 11C-Methionine PET-MRI Receives: Other: 11C-Methionine PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI
diagnosis accuracy of 11C-MET PET-MRI to differentiated pseudoprogression from tumor recurrence, compared to MRI. The gold-standard being retrospective MRI analysis.
Measured: within 1 months and 12 months post-treatment
Secondary outcomes (3)
ROC curves for comparison of two diagnostic tests: MRI and PET-MRI
use of area under the curve for each tests to identify the best
Measured: within 1 months and 24 months after inclusion
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the methylation status of the O6-methylguanine-DNA- methyltransferase (MGMT) promoter, the level of expression of isocitrate dehydrogenase (IDH) mutation, ki67 and 1p19q mutation.
Measured: during 24 months after inclusion
Overall survival analysis
Patients will be followed regularly for 2 years to assess overall survival at 12 months and at 24 months.
Measured: during 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start26 Feb 2019
- Primary completion26 Feb 2020 (estimated)
- Study completion26 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DUCRAY François, Principal investigator, Hospîces Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739333
- Sponsor's protocol ID
- 69HCL18_0265
- Other IDs
- 2018-002016-27, 2018
- Acronym
- TIGRE
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.
- ClinicalTrials.gov ID
- NCT03739333
- Acronym / sponsor ID
- TIGRE / 69HCL18_0265
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, 11C-Methionine PET-MRI, sensitivity, temozolomide, radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 26 Feb 2020 (estimated)
- Study completion
- 26 Jan 2025 (estimated)
- First posted
- 13 Nov 2018 (actual)
- 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.
Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma.
Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis.
The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with glioblastoma | Experimental | Other: 11C-Methionine PET-MRIimplementation of 11C-Methionine PET-MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 or over,
- Patient with glioblastoma treated by radiochemotherapy with temozolomide,
- Patient with suspicion of pseudoprogression between the 1st and 12th month after the end of concomitant chemoradiotherapy,
- Patient receiving a social security scheme,
- Patient for whom informed and written consent to participate has been obtained,
Key exclusion criteria (8 listed)
- Subject under safeguard of justice (tutelage, curatorship),
- Minor patient,
- Patient without signs of progression MRI (stable disease or good response to treatment according to the RANO 2010 criteria),
- Clinical or radiological progression justifying a change of treatment,
- Patient not able to decide and with refusal of the family entitled to continue research.
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 |
|---|---|---|
| 11C-Methionine PET-MRIImplementation 11C-Methionine PET-MRI performed for each patient in one place (department of nuclear medicine of Hospices Civils de Lyon). The 11C-Methionine PET-MRI will be performed after radiochemotherapy in patients with MRI suspicious of pseudoprogression. | Other | patients with glioblastoma |
Primary outcome
false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI
Time frame: within 1 months and 12 months post-treatment
diagnosis accuracy of 11C-MET PET-MRI to differentiated pseudoprogression from tumor recurrence, compared to MRI. The gold-standard being retrospective MRI analysis.
3 secondary outcomes
ROC curves for comparison of two diagnostic tests: MRI and PET-MRI
Time frame: within 1 months and 24 months after inclusion
The proportion of pseudoprogression identified by PET-MRI to 11C-MET according to the genetic data
Time frame: during 24 months after inclusion
Overall survival analysis
Time frame: during 24 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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.
DUCRAY François principal investigator
Hospîces Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-Methionine PET-MRI in people with Glioblastoma, run by Hospices Civils de Lyon at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DUCRAY François, MD (00 (33) 4 72 68 13 21, francois.ducray@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
false negatives and false positives description (diagnosis accuracy) of 11C-Methionine PET-MRI (time frame: within 1 months and 12 months post-treatment). 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 13 Feb 2020.