Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Brain Tumors
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-11-24, after 2020-09-25 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 2025-11-24. 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: tumortumorsulnresectionto determine
Phrases that lowered it: pharmacokineticssafetyadministrationsingleclinical -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Primary purpose: diagnostic (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 20.3% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Collaborators: 2 (lowers risk) · Design
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Maximum age: 17 (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 1 (raises risk) · Sponsor's track record
-
Blinding: none (raises risk) · Design
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Allocation: not applicable (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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- diagnostic (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 680 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 224 (typical: 412.5)
- Drug's FAERS reports marked serious
- 20.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology
- 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
- A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors NCT01128218 · started 2011 · scored riskier than 97% of active trials completed
- Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain NCT01116661 · started 2010 · scored riskier than 99% of active trials terminated
- Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain NCT00671710 · started 2008 · scored riskier than 98% of active trials completed
- Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery NCT00961090 · started 2009 · scored riskier than 99% of active trials completed
- The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial NCT05101798 · started 2021 · scored riskier than 99% 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.