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Brain tumor breakthrough? simple blood test could replace risky biopsies

NCT ID NCT07420543

Knowledge-focused Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study tests whether a substance called 5-ALA, already used during brain surgery to make tumor cells glow, can also be detected in blood or urine. Researchers hope this 'liquid biopsy' could help diagnose and monitor glioblastoma, the most common and deadly brain tumor, without repeated surgeries. The study will enroll 30 adults with brain tumors to measure 5-ALA levels at different times.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-aminolevulinic acid (5-ALA)
What this could lead to
If successful, this could lead to a simple blood or urine test to monitor brain tumors, reducing the need for invasive biopsies.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply to all patients. The test may not be accurate enough for routine use.

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.

Participants

About 30 people

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

Started

May 2024

Expected to finish

Dec 2026

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.

Who is studied

30 Patients with brain tumors whose treatment course involves fluorescence-guided surgery 5-ALA.

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: * Inclusion Criteria (Glioblastoma Patients): * Patient aged 18 years or older * Diagnosis of supratentorial glioblastoma at its first occurrence (Grade 4, WHO 2021), confirmed through histological analysis, in a brain area that is accessible for surgical removal. * Ability of the patient to give informed consent. * Suitability for surgery with fluorescence guidance using 5-ALA. Inclusion Criteria (Other Brain Tumors): * Patient aged 18 years or older * Ability of the patient to give informed consent. * Suitability for surgery with fluorescence guidance using 5-ALA. Exclusion Criteria: Exclusion Criteria (Glioblastoma Patients): * Presence of other systemic tumors. * Known allergic sensitivity or contraindications to gadolinium. * Contraindications to MRI, such as the presence of non-compatible implanted devices. * Significantly compromised renal function (eGFR \<30 ml/min/1.73 m²), and/or patients undergoing dialysis. * Conditions that contraindicate surgery with fluorescence guidance using 5-ALA. Exclusion Criteria (Other Brain Tumors): * Patients suffering from systemic tumors (besides the primary of the brain metastasis). * Individuals with known allergies or adverse reactions to gadolinium. * Individuals with contraindications for MRI, including those with implants not compatible with the procedure. * Individuals with significantly reduced kidney function (eGFR \< 30 ml/min/1.73 m²), or those undergoing dialysis.

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

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

Brain tumors and/or solid tumors including Glioblastoma Glioblastoma (GBM) Glioblastoma - category

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Italy

More trials for these conditions

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