Diffuse Midline GliomaBABY-PULSARNCT07918105
A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas.
A study testing Pulsed Low-Dose-Rate Radiotherapy, pLDRT in people with Diffuse Midline Glioma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Diffuse Midline Glioma
- What is being tested?
- Pulsed Low-Dose-Rate Radiotherapy, pLDRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2026to 15 Jul 2030
- 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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Radiological and/or histological diagnosis of diffuse midline glioma (DMG).
- Ability to maintain the treatment position or undergo sedation, if required.
- Written informed consent provided by the parent(s) or legal guardian(s), or by the patient if aged ≥18 years.
Who cannot join
- Refusal to undergo radiotherapy (i.e., lack of signed informed consent).
- Concurrent chemotherapy.
- Leptomeningeal dissemination of disease.
- Ongoing pregnancy (for post-pubertal female patients).
- Previous radiotherapy to the brainstem.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncolgico -IRCCS
Aviano, Pordenone, 33081
Elisa Coassin, 0434659632, ecoassin@cro.it
Elisa Coassin
About this study
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
Read the detailed description
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
- Conditions
- Diffuse Midline Glioma
- Being tested
- Pulsed Low-Dose-Rate Radiotherapy, pLDRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Low-Dose-Rate Radiotherapy, pLDRTRadiation
The radiotherapy treatment will preferably be delivered using volumetric modulated arc therapy (VMAT) with high-energy photons (6 MV), including 6 MV flattening filter-free (FFF) beams when appropriate. In selected cases, intensity-modulated radiotherapy (IMRT) may be used.
| Study group | Role | What they receive |
|---|---|---|
| Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT) | Experimental | Not described Receives: Radiation: Pulsed Low-Dose-Rate Radiotherapy, pLDRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale
Measured: Up to 5 years
Secondary outcomes (10)
To evaluate the median time to local disease progression.
Median progression-free survival (PFS) defined as the time from treatment initiation to the first documented disease progression or death from any cause. Disease progression will be defined according to the RAPNO criteria for pediatric patients and the RANO criteria for adult patients.
Measured: Up to 5 years
To evaluate median overall survival.
Median overall survival (OS), defined as the time from treatment initiation to death from any cause.
Measured: Up to 5 years
To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
Frequency of neurological toxicities
Measured: Up to 5 years
To assess changes in neurological symptoms compared with baseline.
Change in frequencies of neurological symptoms
Measured: Up to 5 years
To evaluate corticosteroid use during radiotherapy.
Dexamethasone dose (mg/day) mean
Measured: Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method
Measured: Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method
Measured: Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method
Measured: Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method
Measured: Up to 5 years
To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule.
Mean of median levels of biomarkers of inflammatory and immune profile
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start13 May 2026
- Primary completion15 Jul 2030 (estimated)
- Study completion15 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Midline GliomaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918105
- Sponsor's protocol ID
- CRO-2025-21
- Acronym
- BABY-PULSAR
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas.
- ClinicalTrials.gov ID
- NCT07918105
- Acronym / sponsor ID
- BABY-PULSAR / CRO-2025-21
- Conditions
- Diffuse Midline Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 15 Jul 2030 (estimated)
- Study completion
- 15 Jul 2030 (estimated)
- First posted
- 5 Nov 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.
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
Detailed description
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT) | Experimental | Radiation: Pulsed Low-Dose-Rate Radiotherapy, pLDRT |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Radiological and/or histological diagnosis of diffuse midline glioma (DMG).
- Ability to maintain the treatment position or undergo sedation, if required.
- Written informed consent provided by the parent(s) or legal guardian(s), or by the patient if aged ≥18 years.
Key exclusion criteria (5 listed)
- Refusal to undergo radiotherapy (i.e., lack of signed informed consent).
- Concurrent chemotherapy.
- Leptomeningeal dissemination of disease.
- Ongoing pregnancy (for post-pubertal female patients).
- Previous radiotherapy to the brainstem.
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 |
|---|---|---|
| Pulsed Low-Dose-Rate Radiotherapy, pLDRTThe radiotherapy treatment will preferably be delivered using volumetric modulated arc therapy (VMAT) with high-energy photons (6 MV), including 6 MV flattening filter-free (FFF) beams when appropriate. In selected cases, intensity-modulated radiotherapy (IMRT) may be used. | Radiation | Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT) |
Primary outcome
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Time frame: Up to 5 years
Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale
10 secondary outcomes
To evaluate the median time to local disease progression.
Time frame: Up to 5 years
To evaluate median overall survival.
Time frame: Up to 5 years
To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
Time frame: Up to 5 years
To assess changes in neurological symptoms compared with baseline.
Time frame: Up to 5 years
To evaluate corticosteroid use during radiotherapy.
Time frame: Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Time frame: Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Time frame: Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
Time frame: Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
Time frame: Up to 5 years
To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule.
Time frame: Up to 5 years
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 5 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Low-Dose-Rate Radiotherapy, pLDRT in people with Diffuse Midline Glioma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 Italy. 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 Elisa Coassin, MD (+39 0434 659632, ecoassin@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.