Non Invasive Diagnosis of GliomaIDASPENCT01703962
Non Invasive IDentification of Gliomas With IDH1 Mutation
An observational study of Non Invasive Diagnosis of Glioma, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Invasive Diagnosis of Glioma
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2012to 20 Mar 2014
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the active file of patients with glioma II or III, followed at the Pitié-Salpetrière Hospital, and whose status is known for IDH1.
Who may be able to join
- Affiliated to Health Insurance regimen (sécurité sociale)
- Patient of 18 years or more
- written informed consent
- Glioma grade II or III histologically proven
- Frozen samples available
- Known status IDH1/IDH2
- Presence of a measurable residual tumor (> 2 cm in diameter FLAIR)
- Karnofsky Performance Status (KPS)> 60
Who cannot join
- Contraindication to MRI *
- The rare patients with IDH2 mutation or with non Arg132His IDH1 mutation will be excluded
- Inability to provide informed consent
- Patient under guardianship or deprived of liberty by court
Trial locations and contacts
1 site in 1 country.
France1 site
GH Pitié-Salpêtrière, 47 Bd de l'Hopital,
Paris, Sélectionner..., 75013
About this study
Official title: Non Invasive IDentification of Gliomas With IDH1 Mutation by Free Plasmatic DNA Analysis, 2-hydroxyglutarate Dosage in the Urines and 2-hydroxyglutarate Detection by Brain SPEctro-MRI: Diagnostic and Follow-up Application (IDASPE)
The recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.
The main objective is to identify the patients with IDH1 mutated glioma by three complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA), biochemical (2-HG dosage in the urine of patients) and radiological (2-HG
Read the detailed description
Our preliminary results indicate an extremely high amount of D-2HG in gliomas and CSF of the patients, and therefore the possibility to detect its presence by spectro-MRI, and to establish a non-invasive diagnosis of glioma with IDH1 mutation. Our goal is to identify and quantify by high-field MRI spectroscopy the presence of D-2HG to identify gliomas with IDH1 mutation. In parallel, we developed a technique for selective amplification of the mutated form of IDH1 (COLD PCR): by combining this technique with digital PCR, we already are able to detect IDH1 mutation from free plasma DNA with a sensitivity of 58% and a specificity of 100%. At the same time we have shown that D-2HG levels in urine of patients correlate with the status of the tumor IDH1.
The main objective is to identify using this triple approach (detection of the mutation on plasma DNA detection, detection of urinary D-2HG, detection of tumor D-2HG by spectro-MRI) patients with IDH1arg132His mutation, the secondary objective is to evaluate the value of these markers for patients follow-up and for differentiating recurrence from treatment induced damage. 40 patients with grade II and grade III gliomas (20 mutated, 20 non mutated) will be included and followed up for one year (five measurements are planned).
The first interest is diagnostic: the presence of the IDH1Arg132His mutation allows the diagnosis of glioma. This information is particularly valuable in patients not amenable to biopsy, because of the location of the tumor considered at risk, the general condition of the patient or the co-morbidities and medications. We hope also with these parameters to better monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and radionecrosis or post-radiation leukoencephalopathy.
- Conditions
- Non Invasive Diagnosis of Glioma
- Keywords
- Glioma, IDH1, Spectroscopy, Plasma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IDH1 R132H or wild type IDH1/IDH2 glioma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of IDH1/2 mutation
Using patient's plasma DNA
Measured: Day 1
Detection of tumor D-2HG by spectro-MRI
By Magnetic Resonance Spectrometry or Spectroscopy (MRS)
Measured: Day 1, 3 Month, 6 Month, 9 Month, 12 Month
Measurement of 2- HG (D-2-hydroxyglutarate)
In patients' urine
Measured: Day 1, 3 Month, 6 Month, 9 Month, 12 Month
Analysis of circulating tumor DNA
Using a plasma sample
Measured: Day 1, 3 Month, 6 Month, 9 Month, 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study start14 Mar 2012
- Primary completionMar 2014
- Study completion20 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Invasive Diagnosis of GliomaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marc SANSON, MDPhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703962
- Sponsor's protocol ID
- C11-28
- Other IDs
- 2011-A01356-35
- Acronym
- IDASPE
- Status last verified
- Aug 2021
- First submitted
- 8 Oct 2012
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Branzoli F, Liserre R, Deelchand DK, Poliani PL, Bielle F, Nichelli L, Sanson M, Lehericy S, Marjanska M. Neurochemical Differences between 1p/19q Codeleted and Noncodeleted IDH-mutant Gliomas by in Vivo MR Spectroscopy. Radiology. 2023 Sep;308(3):e223255. doi: 10.1148/radiol.223255.
PubMed 37668523
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive IDentification of Gliomas With IDH1 Mutation by Free Plasmatic DNA Analysis, 2-hydroxyglutarate Dosage in the Urines and 2-hydroxyglutarate Detection by Brain SPEctro-MRI: Diagnostic and Follow-up Application (IDASPE)
- ClinicalTrials.gov ID
- NCT01703962
- Acronym / sponsor ID
- IDASPE / C11-28
- Conditions
- Non Invasive Diagnosis of Glioma
- Keywords
- Glioma, IDH1, Spectroscopy, Plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 14 Mar 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- 20 Mar 2014 (actual)
- First posted
- 11 Oct 2012 (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 recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.
The main objective is to identify the patients with IDH1 mutated glioma by three complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA), biochemical (2-HG dosage in the urine of patients) and radiological (2-HG
Detailed description
Our preliminary results indicate an extremely high amount of D-2HG in gliomas and CSF of the patients, and therefore the possibility to detect its presence by spectro-MRI, and to establish a non-invasive diagnosis of glioma with IDH1 mutation. Our goal is to identify and quantify by high-field MRI spectroscopy the presence of D-2HG to identify gliomas with IDH1 mutation. In parallel, we developed a technique for selective amplification of the mutated form of IDH1 (COLD PCR): by combining this technique with digital PCR, we already are able to detect IDH1 mutation from free plasma DNA with a sensitivity of 58% and a specificity of 100%. At the same time we have shown that D-2HG levels in urine of patients correlate with the status of the tumor IDH1.
The main objective is to identify using this triple approach (detection of the mutation on plasma DNA detection, detection of urinary D-2HG, detection of tumor D-2HG by spectro-MRI) patients with IDH1arg132His mutation, the secondary objective is to evaluate the value of these markers for patients follow-up and for differentiating recurrence from treatment induced damage. 40 patients with grade II and grade III gliomas (20 mutated, 20 non mutated) will be included and followed up for one year (five measurements are planned).
The first interest is diagnostic: the presence of the IDH1Arg132His mutation allows the diagnosis of glioma. This information is particularly valuable in patients not amenable to biopsy, because of the location of the tumor considered at risk, the general condition of the patient or the co-morbidities and medications. We hope also with these parameters to better monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and radionecrosis or post-radiation leukoencephalopathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IDH1 R132H or wild type IDH1/IDH2 glioma | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the active file of patients with glioma II or III, followed at the Pitié-Salpetrière Hospital, and whose status is known for IDH1.
Key inclusion criteria (8 listed)
- Affiliated to Health Insurance regimen (sécurité sociale)
- Patient of 18 years or more
- written informed consent
- Glioma grade II or III histologically proven
- Frozen samples available
Key exclusion criteria (4 listed)
- Contraindication to MRI *
- The rare patients with IDH2 mutation or with non Arg132His IDH1 mutation will be excluded
- Inability to provide informed consent
- Patient under guardianship or deprived of liberty by court
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of IDH1/2 mutation
Time frame: Day 1
Using patient's plasma DNA
Detection of tumor D-2HG by spectro-MRI
Time frame: Day 1, 3 Month, 6 Month, 9 Month, 12 Month
By Magnetic Resonance Spectrometry or Spectroscopy (MRS)
Measurement of 2- HG (D-2-hydroxyglutarate)
Time frame: Day 1, 3 Month, 6 Month, 9 Month, 12 Month
In patients' urine
Analysis of circulating tumor DNA
Time frame: Day 1, 3 Month, 6 Month, 9 Month, 12 Month
Using a plasma sample
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 21 Oct 2026.
- Results publication: PubMed 37668523Branzoli F, Liserre R, Deelchand DK, Poliani PL, Bielle F, Nichelli L, Sanson M, Lehericy S, Marjanska M. Neurochemical Differences between 1p/19q Codeleted and Noncodeleted IDH-mutant Gliomas by in Vivo MR Spectroscopy. Radiology. 2023 Sep;308(3):e223255. doi: 10.1148/radiol.223255.
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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.
Marc SANSON, MDPhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Invasive Diagnosis of Glioma, run by Institut National de la Santé Et de la Recherche Médicale, France 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 8 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 21 Oct 2026. 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?
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?
Identification of IDH1/2 mutation (time frame: Day 1). The study lists 4 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 NCT01703962, which also lists 1 linked publication.
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 21 Oct 2026.