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Enrolling by invitationNCT07925151PHOTON-CTOUpdated Nov 9, 2026

First Pass Spectral Perfusion From Photon Counting CT

An observational study in Coronary Arterial Disease, Myocardial Perfusion Imaging and Chronic Total Occlusion (CTO), sponsored by Medical University of Silesia. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Medical University of Silesia · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

The advent of spectral detector CT scanners represents a potential paradigm shift in imaging. By employing advanced detector technology capable of measuring the energy of individual photons, these systems enable detailed tissue characterization. This includes the potential identification of iodine retention within decreased perfusion or myocardial scar tissue - an ability not previously achievable with conventional CT - thereby expanding diagnostic capabilities that were previously limited to modalities such as transthoracic echocardiography (TTE), cardiac magnetic resonance (CMR), single-photon emission computed tomography (SPECT) or positron emission tomography (PET).

Read the detailed description

Aim The aim of this study is to validate the automatic myocardial tissue analysis using non-invasive first-pass perfusion coronary CT angiography (CTA) acquired on a photon-counting CT system, with the goal of facilitating routine detection of myocardial perfusion defects in patients with chronic total occlusion of coronary artery. The diagnostic performance of this approach will be evaluated against established clinical reference standards.

Hypothesis Spectral CCTA will enable a one stop shop assessment of myocardial perfusion defects in patients with chronic total occlusion of coronary artery.

Methods The study informed consent was waived based on the retrospective nature of the study (Institutional Review Board of Medical University of Silesia, decision number BNW/NWN/0052/KB1/108/26). This multicenter study will include patients with chronic total occlusion of a coronary artery. Eligibility requires prior coronary CTA performed using photon-counting CT with spectral protocol, as well as at least one reference standard modality, including perfusion SPECT, perfusion PET, CMR with perfusion and/or late gadolinium enhancement (LGE), stress or rest TTE. The reference scan should be performed within six months of CCTA scan. CCTA and reference scan must be performed prior to revascularisation. Revascularisation is not required for patient inclusion. For the CCTA, each of the file must be spectral. CCTA datasets will be automatically analysed using an in-house developed software and classified as normal or hypoperfused, using the reference imaging modality as the standard of comparison.

This multicentre study will include patients with a chronic total occlusion (CTO) of a coronary artery. Eligible patients must have undergone coronary CT angiography (CCTA) using photon-counting CT with a spectral acquisition protocol, as well as at least one reference-standard imaging examination.

Acceptable reference modalities include perfusion single-photon emission computed tomography (SPECT), perfusion positron emission tomography (PET), cardiovascular magnetic resonance (CMR) incorporating perfusion imaging and/or late gadolinium enhancement (LGE), and stress or rest transthoracic echocardiography (TTE).

The reference-standard examination must have been performed within six months of the CCTA examination. Both the CCTA and the reference-standard examination must have been acquired before any coronary revascularisation procedure. Revascularisation is not a prerequisite for study inclusion.

All CCTA datasets submitted for analysis must include spectral data. The CCTA datasets will undergo automated analysis using internally developed software and will be classified as either normal or hypoperfused, with the findings of the corresponding reference-standard imaging modality serving as the comparator

02

Conditions studied

  • Coronary Arterial Disease
  • Myocardial Perfusion Imaging
  • Chronic Total Occlusion (CTO)

Keywords

  • photon counting CT
  • myocardial first pass perfusion
03

In context

Lead sponsor

Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a confirmed chronic total occlusion (CTO) of at least one coronary artery who have both a photon-counting CT coronary angiography (CCTA) scan and a reference imaging examination available, with both examinations performed within a 6-month interval.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Presence of one coronary artery with a chronic total occlusion (CTO).
  • Availability of coronary CT angiography (CCTA) acquired using a photon-counting CT scanner, with spectral data available (SPP file).
  • Availability of at least one reference-standard imaging examination:

Transthoracic echocardiography (TTE). Single-photon emission computed tomography (SPECT). Positron emission tomography (PET). Magnetic resonance imaging (MRI).

- The interval between the CCTA examination and the reference-standard imaging examination must not exceed six months.

Exclusion criteria

Exclusion Criteria:

  • History of coronary artery bypass grafting (CABG).
  • Coronary revascularisation performed before either the spectral CCTA examination or the reference-standard imaging examination.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Diagnostic performance of spectral coronary computed tomography angiography (CCTA) for the detection of myocardial perfusion defects in patients with chronic total occlusion (CTO) of the coronary arteries.

    To evaluate the ability of spectral CCTA to identify myocardial perfusion defects in the myocardial territory supplied by a CTO vessel, using an appropriate reference standard for myocardial perfusion assessment, and an automatic method for tissue analysis. The study will investigate whether spectral CCTA can provide an integrated, one-stop assessment of coronary anatomy and myocardial perfusion.

    Time frame: 20 months

07

Study locations

1 site
  • Department of Cardiology and Structural Heart Diseases
    Katowice, 49-635, Poland
08

References and documents

Individual participant data

Plan to share: Yes — Demographic and clinical characteristics (appropriately de-identified). Coronary anatomy and CTO characteristics. Quantitative and qualitative spectral CCTA measurements. Myocardial perfusion parameters from the reference imaging examination. Diagnostic performance data, including sensitivity, specificity and agreement between imaging methods.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: From November 1st 2026 to June 30th 2028

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2026 (actual). Primary completion is estimated for Jun 2028, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2026
First posted
Nov 9, 2026
StartActual
Nov 1, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925151
Responsible party
Magdalena Dobrolińska (MD, PhD, Medical University of Silesia) — Principal investigator
First posted
Nov 9, 2026
Start date
Nov 1, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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