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
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