HeadNCT07108205
Image Quality Study of Spectral Precise Image CT 7700
An observational study of Head and Body, run by Philips Clinical & Medical Affairs Global at 3 sites in United States.
Trial summary
The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference. Read more about this study
- Who is it for?
- Ages 22 years and older
- What is being tested?
- Paired reading analysis
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jul 2025to 14 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from subjects that met ALL of the inclusion criteria and NONE of the exclusion criteria will be included in this study
Who may be able to join
- • Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols.
- Subjects age > twenty-two (22) years
Who cannot join
- • Scans that the site radiologists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement)
- Scans that are not completed due to technical difficulties
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Montefiore
New York, New York, 10467
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jefferson Einstein
Philadelphia, Pennsylvania, 19107
About this study
Official title: Clinical Study for Spectral Precise Image (SPI) Algorithm
The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference.
Read the detailed description
Spectral Precise Image is a reconstruction technique where the system uses a trained deep learning neural network to produce an image that reduces noise while improving low contrast detectability and maintaining the appearance of traditional filtered back projection (FBP) images.
Spectral Precise Image in Spectral CT 7700 system supports both conventional and spectral reconstructions.
The study will use raw data of subjects that are over the age of 22 years and scanned by Philips Spectral CT.
Study raw data, following anonymization, will be transferred to Philips for reconstructions, both conventional and spectral images will be reconstructed with iDose4 and with Spectral Precise Image at 100% dose.
- Being tested
- Paired reading analysis
- Keywords
- CT, Tomography, Image Quality, Noise reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired reading analysisDevice
Paired side be side evaluation Each reader will assess- Image Quality (IQ) \& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale
| Study group | Role | What they receive |
|---|---|---|
| Raw data will be reconstructed with iDose4 | Raw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with iDose4 Receives: Device: Paired reading analysis | |
| Raw data will be reconstructed with Spectral Precise Image | Raw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with Spectral Precise Image Receives: Device: Paired reading analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images
Primary Endpoint (Co-Primary endpoints):
- The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to) iDose4 for conventional images.
Measured: 1 day
Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
Primary Endpoint (Co-Primary endpoints): 2. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
Measured: 1 day
Secondary outcomes (4)
Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images
- To evaluate the difference in Image Quality (IQ) and diagnostic confidence between Spectral Precise Image reconstructions for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head) and iDose4 for conventional images.
Measured: 1 day
Evaluation of the success rate for Spectral Precise Image reconstruction
- To evaluate the success rate (%) for Spectral Precise Image reconstructions
Measured: 1 day
Evaluation of the interobserver agreement level for the Co-Primary endpoints
- The interobserver agreement level for the Co-Primary endpoints is more than 0.8.
Measured: 1 day
Evaluation of images artifacts visualization and preservation of important features
- Evaluation of images artifacts visualization and preservation of important features and clinical impact on diagnostic ability.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start16 Jul 2025
- Primary completion14 Oct 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108205
- Sponsor's protocol ID
- PD-300450
- Status last verified
- Dec 2025
- First submitted
- 19 May 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Spectral Precise Image (SPI) Algorithm
- ClinicalTrials.gov ID
- NCT07108205
- Acronym / sponsor ID
- PD-300450
- Keywords
- CT, Tomography, Image Quality, Noise reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference.
Detailed description
Spectral Precise Image is a reconstruction technique where the system uses a trained deep learning neural network to produce an image that reduces noise while improving low contrast detectability and maintaining the appearance of traditional filtered back projection (FBP) images.
Spectral Precise Image in Spectral CT 7700 system supports both conventional and spectral reconstructions.
The study will use raw data of subjects that are over the age of 22 years and scanned by Philips Spectral CT.
Study raw data, following anonymization, will be transferred to Philips for reconstructions, both conventional and spectral images will be reconstructed with iDose4 and with Spectral Precise Image at 100% dose.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raw data will be reconstructed with iDose4 | – | Device: Paired reading analysisRaw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with iDose4 |
| Raw data will be reconstructed with Spectral Precise Image | – | Device: Paired reading analysisRaw data of subjects included in the study, following anonymization, will be transferred to Philips for reconstruction, raw data will be reconstructed with Spectral Precise Image |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from subjects that met ALL of the inclusion criteria and NONE of the exclusion criteria will be included in this study
Key inclusion criteria (2 listed)
- • Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols.
Key exclusion criteria (2 listed)
- • Scans that the site radiologists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paired reading analysisPaired side be side evaluation Each reader will assess- Image Quality (IQ) \& Diagnostic Confidence Ratings will be recorded using a 5-point Likert scale | Device | Raw data will be reconstructed with Spectral Precise Image, Raw data will be reconstructed with iDose4 |
Primary outcome
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images
Time frame: 1 day
Primary Endpoint (Co-Primary endpoints): 1. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to) iDose4 for conventional images.
Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
Time frame: 1 day
Primary Endpoint (Co-Primary endpoints): 2. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
4 secondary outcomes
Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images
Time frame: 1 day
Evaluation of the success rate for Spectral Precise Image reconstruction
Time frame: 1 day
Evaluation of the interobserver agreement level for the Co-Primary endpoints
Time frame: 1 day
Evaluation of images artifacts visualization and preservation of important features
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Body, run by Philips Clinical & Medical Affairs Global at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.