Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401)
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2026-02-09, after 2025-01-27 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2026-02-09. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientchemotherapystandardtumorcancer
Phrases that lowered it: disordersafety ofbleedingevaluatepatients who -
Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 17.7% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 1.3% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1431 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 233 (typical: 412.5)
- Drug's FAERS reports marked serious
- 17.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- aminolevulinic acid
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma NCT05362409 · started 2022 · scored riskier than 49% of active trials completed
- Sonodynamic Therapy With ExAblate System in Glioblastoma Patients NCT04845919 · started 2023 · scored riskier than 60% of active trials completed
- Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma NCT04469699 · started 2021 · scored riskier than 64% of active trials terminated
- Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas NCT04659421 · started 2020 · scored riskier than 53% of active trials completed
- Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection NCT04608812 · started 2021 · scored riskier than 64% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.