Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
Model scores of the 29,894 trials active now.
Model score 40% for any early termination, 19% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-04-23, after 2009-09-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2015-04-23. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: tumorbrainmripotential mustperformance
Phrases that lowered it: lightoralultravioletcriteriahistory -
Drug's FAERS reports with a death: 77.8% (raises risk) · Drug's FDA history
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Responsible party: sponsor investigator (raises risk) · Design
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Number of arms: 1 (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
-
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
- 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 investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 9 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 77.8% (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 Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors NCT01351519 · started 2011 · 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
- Aminolevulinic Acid During Surgery in Treating Patients With Malignant Brain Tumors NCT01148966 · started 2010 · scored riskier than 92% of active trials terminated
- 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
- 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
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.