Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System

NCT03103061 on ClinicalTrials.gov Phase 2 Medical University of South Carolina (academic or other) Started 2016-02-09 Completed

Riskier than 85% of active trials

Model scores of the 29,894 trials active now.

Model score 24% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-06-14, after 2016-02-09 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 2018-06-14. 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: subject hascopdsubject ishourssubject must
Phrases that lowered it: mgasthmammevaluate thereceived
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 12.3% (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports marked serious: 58.0% (lowers risk) · Drug's FDA history
Phase: 2 (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: diagnostic (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 67 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 3.3% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 179 (lowers risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Maximum age: 85 (lowers risk) · Who can join
Disease area, cardiovascular: Yes (raises risk) · Disease area
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: diagnostic (typical: treatment)
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 85 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 179 (typical: 32)
Sponsor's past termination rate: 12.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 67 (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: 2105 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 302 (typical: 412.5)
Drug's FAERS reports marked serious: 58.0% (typical: 85.6%)
Drug's FAERS reports with a death: 3.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: regadenoson

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

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Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD NCT05885841 · started 2022 · scored riskier than 33% of active trials completed
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI NCT01313572 · started 2011 · scored riskier than 50% of active trials terminated
A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT) NCT01618669 · started 2012 · scored riskier than 45% 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.