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New scan may reveal brain tumor drug effects in weeks, not years

NCT ID NCT07469735

Knowledge-focused Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a special PET scan (18F-AGX) can detect early changes in brain tumor activity in adults with slow-growing IDH-mutant gliomas who are taking the drug Vorasidenib. Ten participants will get the drug daily for about a year and have multiple PET and MRI scans to see if metabolic changes predict tumor shrinkage or growth. The goal is to find a faster way to tell if the treatment is working, instead of waiting months or years for standard MRI results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or molecularly confirmed WHO 2021 grade 2 or 3 IDH1/2-mutant diffuse glioma with recurrent or residual disease 2. At least one measurable non-enhancing lesion (≥1 cm × ≥1 cm) on postoperative T2/FLAIR MRI 3. Eligible for Vorasidenib treatment 4. Age ≥18 years 5. Karnofsky Performance Status (KPS) score ≥80 6. Adequate hematologic function 7. Adequate renal function 8. Adequate hepatic function 9. Ability to provide written informed consent Exclusion Criteria: 1. Prior treatment with radiotherapy, chemotherapy, or IDH inhibitors 2. Known contraindications to Vorasidenib 3. Contraindications to PET/CT imaging 4. Uncontrolled hyperglycemia 5. Pregnancy or breastfeeding 6. Inability to undergo repeated intravenous injections 7. Known hypersensitivity to imaging agents or study-related medications 8. Use of strong CYP1A2 inhibitors or CYP2C19 or CYP3A substrates with narrow therapeutic index 9. Any serious comorbid condition that may interfere with study participation or safety

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Conditions

The condition(s) this trial relates to.

diffuse astrocytoma glioma malignant glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse glioma GLIOMA Recurrent gliomas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huashan Hospital

    Shanghai, Shanghai Municipality, 201100, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.