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Sound waves and a drug team up to fight brain tumors

NCT ID NCT07076472

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This early-phase trial tests a new treatment for glioblastoma that has come back or is getting worse. The therapy combines a drug called 5-ALA with focused ultrasound waves to target and kill tumor cells without surgery. Eight adults with recurrent glioblastoma will receive the treatment to find the safest dose and see if it helps control the disease.

What this could mean

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

Active substance
aminolevulinic acid hydrochloride (5-ALA HCl) combined with focused ultrasound
What this could lead to
If it works, this could point toward a new non-invasive treatment option for recurrent glioblastoma that may slow tumor growth.
What could go wrong
This is a very early, small pilot study with only 8 participants, so results may not apply broadly. The treatment may not be effective or could cause side effects.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 8 people

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

Started

Aug 2025

Expected to finish

Dec 2031

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: * Age ≥ 18 years * Diagnosis of recurrent or progressive glioblastoma (as defined in 2021 World Health Organization \[WHO\] Classification of Tumors of the Central Nervous System; Louis, Perry, et al. 2021) for which resection is not indicated as assessed by the study physician * Radiographic evidence of disease which may be measurable or non-measurable * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Previous treatment with radiotherapy (RT) * Have a life expectancy of ≥ 12 weeks * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration) * Albumin ≥ 3 g/dL (obtained ≤ 15 days prior to registration) * Potassium ≥ lower limit of normal (LLN) (obtained ≤ 15 days prior to registration) * Serum total calcium ≥ LLN (obtained ≤ 15 days prior to registration) * Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration) * Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Willing to participate in the neuro-oncology biorepository \[Institutional Review Board (IRB) 12-003458, principal investigator (PI): Jann Sarkaria, MD, PhD\] for collecting and archiving biospecimens samples on neuro-oncology patients * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) Exclusion Criteria: * Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown: * Pregnant persons * Nursing persons * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception * Recurrence ≤ 4 weeks after the completion of RT, defined from the imaging assessment immediately after completion of RT * Three or more prior systemic treatments for recurrent or progressing disease * Diagnosis of porphyria, or hypersensitivity to porphyrins * Failure to recover to grade 1 or baseline from any adverse events (AEs) (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) related to prior anticancer therapy * EXCEPTIONS: Alopecia, lymphopenia, peripheral neuropathy, and ototoxicity ≤ grade 3) * Known history of the following conditions: * Allergy to gadolinium contrast agents * Patients known to be HIV positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Inability to undergo MRI scans * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Patients with platelet count \< 100 * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Or psychiatric illness/social situations that would limit compliance with study requirements * History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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