GliomaVANGUARDNCT07469735
Vorasidenib Guided by AGX PET in Recurrent/Low-grade Glioma
A study testing Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma. in people with Glioma and Diffuse Glioma, run by Huashan Hospital at 1 site in China.
Trial summary
The goal of this prospective, single-arm, open-label clinical trial is to evaluate whether 18F-AGX PET imaging can be used to assess early treatment response and metabolic changes in adult patients with recurrent or residual WHO 2021 grade 2-3 IDH-mutant diffuse glioma receiving Vorasidenib therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Diffuse Glioma, Recurrent Gliomas
- What is being tested?
- Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histologically or molecularly confirmed WHO 2021 grade 2 or 3 IDH1/2-mutant diffuse glioma with recurrent or residual disease
- At least one measurable non-enhancing lesion (≥1 cm × ≥1 cm) on postoperative T2/FLAIR MRI
- Eligible for Vorasidenib treatment
- Age ≥18 years
- Karnofsky Performance Status (KPS) score ≥80
- Adequate hematologic function
Show all 9Show fewer
- Adequate renal function
- Adequate hepatic function
- Ability to provide written informed consent
Who cannot join
- Prior treatment with radiotherapy, chemotherapy, or IDH inhibitors
- Known contraindications to Vorasidenib
- Contraindications to PET/CT imaging
- Uncontrolled hyperglycemia
- Pregnancy or breastfeeding
- Inability to undergo repeated intravenous injections
Show all 9Show fewer
- Known hypersensitivity to imaging agents or study-related medications
- Use of strong CYP1A2 inhibitors or CYP2C19 or CYP3A substrates with narrow therapeutic index
- Any serious comorbid condition that may interfere with study participation or safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital
Shanghai, Shanghai Municipality, 201100
Zhifeng Shi, MD, +86 21 64280718, shizhifeng@fudan.edu.cn
About this study
Official title: 18F-AGX PET for Evaluation of Vorasidenib Response and Tumor Metabolic Changes in Low-grade IDH-Mutant Glioma
The goal of this prospective, single-arm, open-label clinical trial is to evaluate whether 18F-AGX PET imaging can be used to assess early treatment response and metabolic changes in adult patients with recurrent or residual WHO 2021 grade 2-3 IDH-mutant diffuse glioma receiving Vorasidenib therapy.
IDH-mutant diffuse gliomas often show slow tumor growth, making early treatment response difficult to evaluate using conventional structural imaging such as magnetic resonance imaging (MRI). Clinical endpoints such as progression-free survival (PFS) and overall survival (OS) typically require long follow-up periods to detect treatment effects. Therefore, the development of sensitive and noninvasive imaging methods for early evaluation of therapeutic response is needed.
Read more
This study aims to determine whether metabolic changes detected by 18F-AGX PET during Vorasidenib treatment are associated with tumor structural changes and clinical outcomes.
The main questions it aims to answer are:
- Whether early changes in tumor metabolic activity measured by 18F-AGX PET, including percentage change in maximum tumor-to-background ratio (TBRmax), are associated with changes in tumor growth rate (TGR) measured by MRI during treatment.
- Whether early metabolic response detected by 18F-AGX PET imaging after initiation of Vorasidenib treatment can predict subsequent disease progression or tumor growth dynamics.
Participants enrolled in this study will receive oral Vorasidenib once daily for 12 treatment cycles (28 days per cycle), with dosing based on body weight.
Participants will:
- Undergo baseline MRI and 18F-AGX PET imaging following surgery for recurrent or residual disease.
- Receive oral Vorasidenib continuously for 12 cycles.
- Undergo MRI scans at baseline and during treatment cycles 1, 2, 3, 6, 9, and 12 to assess structural tumor changes.
- Undergo 18F-AGX PET/CT scans at baseline and during treatment cycles 1, 2, 3, 6, and 12 to assess metabolic tumor activity.
- Provide serial blood samples for laboratory safety monitoring, including hematologic and biochemical testing.
- Undergo magnetic resonance spectroscopy (MRS) to quantify intratumoral 2-hydroxyglutarate (2-HG) levels as an indicator of IDH mutation-associated metabolic activity.
Participants will be followed for imaging-based disease progression using RANO criteria and for treatment-related adverse events during the study period.
This study will evaluate the feasibility of using 18F-AGX PET imaging as a noninvasive imaging biomarker for early response assessment in IDH-mutant diffuse glioma patients receiving targeted IDH inhibition therapy with Vorasidenib.
Read the detailed description
Diffuse gliomas harboring mutations in isocitrate dehydrogenase (IDH1 or IDH2) represent a biologically distinct subgroup of central nervous system tumors characterized by the accumulation of the oncometabolite D-2-hydroxyglutarate (2-HG). Mutant IDH enzymes catalyze the reduction of α-ketoglutarate to 2-HG, leading to widespread epigenetic dysregulation, impaired cellular differentiation, and altered tumor metabolism. These metabolic alterations are considered key drivers of glioma tumorigenesis and progression.
Vorasidenib is an oral, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes that has demonstrated clinical activity in patients with IDH-mutant diffuse glioma. By selectively inhibiting mutant IDH enzymatic activity, Vorasidenib reduces intratumoral 2-HG production and is expected to modify tumor metabolic processes. However, due to the relatively slow growth kinetics of IDH-mutant gliomas, conventional structural imaging techniques such as magnetic resonance imaging (MRI) may not detect treatment-related changes in tumor size during the early phases of therapy. As a result, reliance on morphologic imaging alone may delay the identification of therapeutic response or disease progression.
Metabolic imaging approaches have the potential to provide earlier indicators of biological treatment effects. Magnetic resonance spectroscopy (MRS) has been used to quantify intratumoral 2-HG concentrations in vivo as a surrogate of mutant IDH activity. While MRS-based measurements may reflect pharmacodynamic effects of IDH inhibition, its sensitivity and spatial resolution may limit its utility for longitudinal monitoring of treatment response in clinical practice.
Positron emission tomography (PET) imaging using radiolabeled tracers enables the quantitative assessment of tumor metabolism and has been shown to detect treatment-related metabolic changes that precede morphologic alterations observed on MRI. Amino acid PET tracers such as 18F-FET and 18F-FDOPA have demonstrated the ability to identify early metabolic responses in glioma patients undergoing systemic therapy, with metabolic response correlating with clinical outcomes in some studies.
18F-AGX is a novel PET radiotracer designed to selectively bind to IDH-mutant glioma cells. Preclinical studies have demonstrated that 18F-AGX crosses the blood-brain barrier and exhibits increased uptake in IDH-mutant glioma models compared with IDH wild-type tumors. In experimental settings, treatment with Vorasidenib has been associated with reductions in tracer uptake that parallel decreases in intratumoral 2-HG levels, suggesting that 18F-AGX PET imaging may serve as a noninvasive indicator of target engagement and metabolic response.
This clinical study is designed to evaluate the feasibility of using 18F-AGX PET imaging to monitor metabolic changes in patients with recurrent or residual IDH-mutant diffuse glioma receiving Vorasidenib therapy. Longitudinal multimodal imaging will be performed during treatment to assess temporal changes in tumor metabolic activity and structural characteristics.
PET imaging will be conducted following intravenous administration of 18F-AGX. Quantitative image analysis will be performed using tumor-to-background uptake metrics derived from standardized uptake values (SUV). Regions of interest will be defined on PET images with reference to co-registered MRI data to allow for spatial correlation between metabolic and structural tumor features.
MRI will be performed using standardized acquisition protocols to assess tumor morphology, including T2-weighted and FLAIR sequences. MR spectroscopy may be performed to quantify intratumoral 2-HG concentrations as a complementary metabolic biomarker associated with mutant IDH activity.
Serial laboratory testing will be conducted throughout the study to monitor participant safety during Vorasidenib treatment. Adverse events will be assessed according to applicable clinical research standards.
Imaging-based disease status will be evaluated using established neuro-oncology response assessment criteria. Participants may receive additional standard-of-care interventions if clinically indicated during or after completion of the treatment period.
The results of this study are intended to provide preliminary clinical data on the use of 18F-AGX PET imaging as a noninvasive method for detecting early metabolic response in IDH-mutant diffuse glioma patients undergoing targeted IDH inhibition therapy.
- Conditions
- Glioma, Diffuse Glioma, Recurrent Gliomas
- Being tested
- Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma.
- Keywords
- IDH Mutation, Vorasidenib, Positron Emission Tomography, Treatment Response
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma.Drug
Positron emission tomography (PET) imaging performed using the investigational IDH-targeted radiotracer 18F-AGX to assess metabolic tumor activity during Vorasidenib treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vorasidenib Treatment with 18F-AGX PET Assessment | Experimental | Participants receive oral Vorasidenib once daily for up to 12 treatment cycles (28 days per cycle). Serial 18F-AGX PET imaging and MRI assessments are performed during treatment to evaluate metabolic and structural tumor changes associated with IDH-targeted therapy. Receives: Drug: Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor Metabolic Activity Assessed by 18F-AGX PET
Percentage change from baseline in maximum tumor-to-background ratio (TBRmax) measured by 18F-AGX PET imaging during Vorasidenib treatment.
Measured: Up to 12 treatment cycles (approximately 12 months)
Secondary outcomes (3)
Tumor Growth Rate Assessed by MRI
Change in tumor growth rate derived from serial volumetric measurements on T2/FLAIR MRI sequences during treatment.
Measured: From baseline to the end of Cycle 12 (each cycle is 28 days; approximately 12 months)
Diagnostic Accuracy of 18F-AGX PET for IDH Mutation Detection
Sensitivity, specificity, positive predictive value, and negative predictive value of 18F-AGX PET imaging for detecting IDH mutation status compared with histopathologic diagnosis.
Measured: At baseline imaging assessment
Incidence of Treatment-Related Adverse Events
Frequency and severity of treatment-related adverse events during Vorasidenib treatment.
Measured: From the first dose of Vorasidenib to the end of Cycle 12 (each cycle is 28 days; approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm interventional study in which all enrolled participants receive oral Vorasidenib treatment for up to 12 treatment cycles. Serial 18F-AGX PET imaging and MRI assessments are performed during treatment to evaluate metabolic and structural tumor changes associated with IDH-targeted therapy. No comparator or control group is included.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SCU West China Lecheng Hospital
- Responsible party
- Principal investigator, Zhifeng Shi, Huashan Hospital
- Investigators
- Zhifeng Shi, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469735
- Sponsor's protocol ID
- HIM-2025-0674
- Acronym
- VANGUARD
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is currently undecided whether individual participant data (IPD) collected in this study will be made available to other researchers. Any future data sharing will be subject to approval by the institutional review board and in accordance with applicable regulatory requirements governing the use and transfer of human subject research data.
Publications
Galldiks N, Werner JM, Stetter I, Puhr HC, Nakuz TS, Stoffels G, Albert NL, Langen KJ, Lohmann P, Preusser M. Evaluation of early metabolic changes following vorasidenib using FET PET in patients with IDH-mutant gliomas. Neurooncol Adv. 2024 Nov 29;6(1):vdae210. doi: 10.1093/noajnl/vdae210. eCollection 2024 Jan-Dec.
PubMed 39737092Cloughesy TF, van den Bent MJ, Touat M, Blumenthal DT, Peters KB, Ellingson BM, Clarke JL, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry J, Giglio P, de la Fuente M, Maher E, Bottomley A, Tron AE, Yi D, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Mellinghoff IK; INDIGO trial investigators. Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1665-1675. doi: 10.1016/S1470-2045(25)00472-3. Epub 2025 Oct 29.
PubMed 41175888
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-AGX PET for Evaluation of Vorasidenib Response and Tumor Metabolic Changes in Low-grade IDH-Mutant Glioma
- ClinicalTrials.gov ID
- NCT07469735
- Acronym / sponsor ID
- VANGUARD / HIM-2025-0674
- Conditions
- Glioma, Diffuse Glioma, Recurrent Gliomas
- Keywords
- IDH Mutation, Vorasidenib, Positron Emission Tomography, Treatment Response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- SCU West China Lecheng Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2026 (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.
The goal of this prospective, single-arm, open-label clinical trial is to evaluate whether 18F-AGX PET imaging can be used to assess early treatment response and metabolic changes in adult patients with recurrent or residual WHO 2021 grade 2-3 IDH-mutant diffuse glioma receiving Vorasidenib therapy.
IDH-mutant diffuse gliomas often show slow tumor growth, making early treatment response difficult to evaluate using conventional structural imaging such as magnetic resonance imaging (MRI). Clinical endpoints such as progression-free survival (PFS) and overall survival (OS) typically require long follow-up periods to detect treatment effects. Therefore, the development of sensitive and noninvasive imaging methods for early evaluation of therapeutic response is needed.
This study aims to determine whether metabolic changes detected by 18F-AGX PET during Vorasidenib treatment are associated with tumor structural changes and clinical outcomes.
The main questions it aims to answer are:
- Whether early changes in tumor metabolic activity measured by 18F-AGX PET, including percentage change in maximum tumor-to-background ratio (TBRmax), are associated with changes in tumor growth rate (TGR) measured by MRI during treatment.
- Whether early metabolic response detected by 18F-AGX PET imaging after initiation of Vorasidenib treatment can predict subsequent disease progression or tumor growth dynamics.
Participants enrolled in this study will receive oral Vorasidenib once daily for 12 treatment cycles (28 days per cycle), with dosing based on body weight.
Participants will:
- Undergo baseline MRI and 18F-AGX PET imaging following surgery for recurrent or residual disease.
- Receive oral Vorasidenib continuously for 12 cycles.
- Undergo MRI scans at baseline and during treatment cycles 1, 2, 3, 6, 9, and 12 to assess structural tumor changes.
- Undergo 18F-AGX PET/CT scans at baseline and during treatment cycles 1, 2, 3, 6, and 12 to assess metabolic tumor activity.
- Provide serial blood samples for laboratory safety monitoring, including hematologic and biochemical testing.
- Undergo magnetic resonance spectroscopy (MRS) to quantify intratumoral 2-hydroxyglutarate (2-HG) levels as an indicator of IDH mutation-associated metabolic activity.
Participants will be followed for imaging-based disease progression using RANO criteria and for treatment-related adverse events during the study period.
This study will evaluate the feasibility of using 18F-AGX PET imaging as a noninvasive imaging biomarker for early response assessment in IDH-mutant diffuse glioma patients receiving targeted IDH inhibition therapy with Vorasidenib.
Detailed description
Diffuse gliomas harboring mutations in isocitrate dehydrogenase (IDH1 or IDH2) represent a biologically distinct subgroup of central nervous system tumors characterized by the accumulation of the oncometabolite D-2-hydroxyglutarate (2-HG). Mutant IDH enzymes catalyze the reduction of α-ketoglutarate to 2-HG, leading to widespread epigenetic dysregulation, impaired cellular differentiation, and altered tumor metabolism. These metabolic alterations are considered key drivers of glioma tumorigenesis and progression.
Vorasidenib is an oral, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes that has demonstrated clinical activity in patients with IDH-mutant diffuse glioma. By selectively inhibiting mutant IDH enzymatic activity, Vorasidenib reduces intratumoral 2-HG production and is expected to modify tumor metabolic processes. However, due to the relatively slow growth kinetics of IDH-mutant gliomas, conventional structural imaging techniques such as magnetic resonance imaging (MRI) may not detect treatment-related changes in tumor size during the early phases of therapy. As a result, reliance on morphologic imaging alone may delay the identification of therapeutic response or disease progression.
Metabolic imaging approaches have the potential to provide earlier indicators of biological treatment effects. Magnetic resonance spectroscopy (MRS) has been used to quantify intratumoral 2-HG concentrations in vivo as a surrogate of mutant IDH activity. While MRS-based measurements may reflect pharmacodynamic effects of IDH inhibition, its sensitivity and spatial resolution may limit its utility for longitudinal monitoring of treatment response in clinical practice.
Positron emission tomography (PET) imaging using radiolabeled tracers enables the quantitative assessment of tumor metabolism and has been shown to detect treatment-related metabolic changes that precede morphologic alterations observed on MRI. Amino acid PET tracers such as 18F-FET and 18F-FDOPA have demonstrated the ability to identify early metabolic responses in glioma patients undergoing systemic therapy, with metabolic response correlating with clinical outcomes in some studies.
18F-AGX is a novel PET radiotracer designed to selectively bind to IDH-mutant glioma cells. Preclinical studies have demonstrated that 18F-AGX crosses the blood-brain barrier and exhibits increased uptake in IDH-mutant glioma models compared with IDH wild-type tumors. In experimental settings, treatment with Vorasidenib has been associated with reductions in tracer uptake that parallel decreases in intratumoral 2-HG levels, suggesting that 18F-AGX PET imaging may serve as a noninvasive indicator of target engagement and metabolic response.
This clinical study is designed to evaluate the feasibility of using 18F-AGX PET imaging to monitor metabolic changes in patients with recurrent or residual IDH-mutant diffuse glioma receiving Vorasidenib therapy. Longitudinal multimodal imaging will be performed during treatment to assess temporal changes in tumor metabolic activity and structural characteristics.
PET imaging will be conducted following intravenous administration of 18F-AGX. Quantitative image analysis will be performed using tumor-to-background uptake metrics derived from standardized uptake values (SUV). Regions of interest will be defined on PET images with reference to co-registered MRI data to allow for spatial correlation between metabolic and structural tumor features.
MRI will be performed using standardized acquisition protocols to assess tumor morphology, including T2-weighted and FLAIR sequences. MR spectroscopy may be performed to quantify intratumoral 2-HG concentrations as a complementary metabolic biomarker associated with mutant IDH activity.
Serial laboratory testing will be conducted throughout the study to monitor participant safety during Vorasidenib treatment. Adverse events will be assessed according to applicable clinical research standards.
Imaging-based disease status will be evaluated using established neuro-oncology response assessment criteria. Participants may receive additional standard-of-care interventions if clinically indicated during or after completion of the treatment period.
The results of this study are intended to provide preliminary clinical data on the use of 18F-AGX PET imaging as a noninvasive method for detecting early metabolic response in IDH-mutant diffuse glioma patients undergoing targeted IDH inhibition therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm interventional study in which all enrolled participants receive oral Vorasidenib treatment for up to 12 treatment cycles. Serial 18F-AGX PET imaging and MRI assessments are performed during treatment to evaluate metabolic and structural tumor changes associated with IDH-targeted therapy. No comparator or control group is included.
| Arm | Type | Receives |
|---|---|---|
| Vorasidenib Treatment with 18F-AGX PET Assessment | Experimental | Drug: Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma.Participants receive oral Vorasidenib once daily for up to 12 treatment cycles (28 days per cycle). Serial 18F-AGX PET imaging and MRI assessments are performed during treatment to evaluate metabolic and structural tumor changes associated with IDH-targeted therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or molecularly confirmed WHO 2021 grade 2 or 3 IDH1/2-mutant diffuse glioma with recurrent or residual disease
- At least one measurable non-enhancing lesion (≥1 cm × ≥1 cm) on postoperative T2/FLAIR MRI
- Eligible for Vorasidenib treatment
- Age ≥18 years
- Karnofsky Performance Status (KPS) score ≥80
Key exclusion criteria (9 listed)
- Prior treatment with radiotherapy, chemotherapy, or IDH inhibitors
- Known contraindications to Vorasidenib
- Contraindications to PET/CT imaging
- Uncontrolled hyperglycemia
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma.Positron emission tomography (PET) imaging performed using the investigational IDH-targeted radiotracer 18F-AGX to assess metabolic tumor activity during Vorasidenib treatment. | Drug | Vorasidenib Treatment with 18F-AGX PET Assessment |
Primary outcome
Change in Tumor Metabolic Activity Assessed by 18F-AGX PET
Time frame: Up to 12 treatment cycles (approximately 12 months)
Percentage change from baseline in maximum tumor-to-background ratio (TBRmax) measured by 18F-AGX PET imaging during Vorasidenib treatment.
3 secondary outcomes
Tumor Growth Rate Assessed by MRI
Time frame: From baseline to the end of Cycle 12 (each cycle is 28 days; approximately 12 months)
Diagnostic Accuracy of 18F-AGX PET for IDH Mutation Detection
Time frame: At baseline imaging assessment
Incidence of Treatment-Related Adverse Events
Time frame: From the first dose of Vorasidenib to the end of Cycle 12 (each cycle is 28 days; approximately 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 39737092Galldiks N, Werner JM, Stetter I, Puhr HC, Nakuz TS, Stoffels G, Albert NL, Langen KJ, Lohmann P, Preusser M. Evaluation of early metabolic changes following vorasidenib using FET PET in patients with IDH-mutant gliomas. Neurooncol Adv. 2024 Nov 29;6(1):vdae210. doi: 10.1093/noajnl/vdae210. eCollection 2024 Jan-Dec.
- Background: PubMed 41175888Cloughesy TF, van den Bent MJ, Touat M, Blumenthal DT, Peters KB, Ellingson BM, Clarke JL, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry J, Giglio P, de la Fuente M, Maher E, Bottomley A, Tron AE, Yi D, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Mellinghoff IK; INDIGO trial investigators. Vorasidenib in IDH1-mutant or IDH2-mutant low-grade glioma (INDIGO): secondary and exploratory endpoints from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1665-1675. doi: 10.1016/S1470-2045(25)00472-3. Epub 2025 Oct 29.
- Individual participant dataSharing planned: Undecided. It is currently undecided whether individual participant data (IPD) collected in this study will be made available to other researchers. Any future data sharing will be subject to approval by the institutional review board and in accordance with applicable regulatory requirements governing the use and transfer of human subject research data.
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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.
Zhifeng Shi, MD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Vorasidenib administered once daily for up to 12 treatment cycles (28 days per cycle) as IDH-targeted therapy in participants with recurrent or residual IDH-mutant diffuse glioma. in people with Glioma and Diffuse Glioma, run by Huashan Hospital at 1 site in China.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 13 Mar 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhifeng Shi, MD (+86 21 64280718, shizhifeng@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tumor Metabolic Activity Assessed by 18F-AGX PET (time frame: Up to 12 treatment cycles (approximately 12 months)). 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 NCT07469735, which also lists 2 linked publications.
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 Mar 2026.