Head and Neck Cancer (H&N)NCT07242690
PET-CT Imaging With PCD-CT
A study testing PCD-CT and PET CT in people with Head and Neck Cancer (H&N), run by Medical University of South Carolina at 1 site in United States.
Trial summary
This pilot study evaluates the clinical utility of photon counting detector computed tomography (PCD-CT) in PET-CT imaging for head and neck cancer. Twenty adult patients undergoing standard-of-care PET-CT will also receive PCD-CT imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N)
- What is being tested?
- PCD-CT and PET CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 1 Jan 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scheduled for or completed standard-of-care PET-CT of head and neck within ≤30 days
Who cannot join
- Non-diagnostic PET-CT
- Intervening therapy between scans
- Iodinated contrast allergy
- Renal insufficiency (GFR < 45)
- Pregnancy
- Gross motion artifacts
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29407
About this study
Official title: Advancing PET-CT Imaging With Photon Counting Detector CT
This pilot study evaluates the clinical utility of photon counting detector computed tomography (PCD-CT) in PET-CT imaging for head and neck cancer. Twenty adult patients undergoing standard-of-care PET-CT will also receive PCD-CT imaging. The study compares image quality and diagnostic confidence between conventional energy-integrating detector CT (EID-CT) and PCD-CT for attenuation correction and anatomical imaging.
- Conditions
- Head and Neck Cancer (H&N)
- Being tested
- PCD-CT, PET CT
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCD-CTOther
A direct qualitative comparison of the subjective PET image quality will be performed.
Two blinded board-certified radiologists/nuclear medicine physicians will independently review PET images constructed using non-contrast PCD-CT data as well as PET images constructed using standard of care non-contrast EID-CT data in random order. Both raters will assess PET images subjectively regarding overall image quality using a five-point Likert scale. The rating will be defined as: (1) non-diagnostic - insufficient diagnostic confidence, (2) poor - low diagnostic confidence, (3) moderate - average diagnostic confidence; (4) good - high diagnostic confidence, and (5) excellent - full diagnostic confidence.
PET CTOther
To compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review.
| Study group | Role | What they receive |
|---|---|---|
| PET CT scan | Other | To compare the image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a quantitative analysis of measurable image quality parameters. Receives: Other: PCD-CT |
| PCD-CT | Other | To compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review. Receives: Other: PET CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve PET image w/ non-contrast PCD-CT data
We expect that the subjective PET image quality will be improved by using non-contrast PCD-CT data for construction resulting in higher diagnostic confidence; demonstrating a case for the integration of PCD-CT into standard of care clinical PET-CT imaging in the future. There will be no direct benefit to study participants and the outcome will not be directly reported to the treatment team or patient and will not impact treatment or care received.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startSep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Why it stopped: Study team is working on contracts.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Sponsor
- Investigators
- Kevin Horn, PhD, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242690
- Sponsor's protocol ID
- Pro00146888
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing PET-CT Imaging With Photon Counting Detector CT
- ClinicalTrials.gov ID
- NCT07242690
- Acronym / sponsor ID
- Pro00146888
- Conditions
- Head and Neck Cancer (H&N)
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study team is working on contracts.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Nov 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.
This pilot study evaluates the clinical utility of photon counting detector computed tomography (PCD-CT) in PET-CT imaging for head and neck cancer. Twenty adult patients undergoing standard-of-care PET-CT will also receive PCD-CT imaging. The study compares image quality and diagnostic confidence between conventional energy-integrating detector CT (EID-CT) and PCD-CT for attenuation correction and anatomical imaging.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET CT scan | Other | Other: PCD-CTTo compare the image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a quantitative analysis of measurable image quality parameters. |
| PCD-CT | Other | Other: PET CTTo compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Scheduled for or completed standard-of-care PET-CT of head and neck within ≤30 days
Key exclusion criteria (6 listed)
- Non-diagnostic PET-CT
- Intervening therapy between scans
- Iodinated contrast allergy
- Renal insufficiency (GFR < 45)
- Pregnancy
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 |
|---|---|---|
| PCD-CTA direct qualitative comparison of the subjective PET image quality will be performed. Two blinded board-certified radiologists/nuclear medicine physicians will independently review PET images constructed using non-contrast PCD-CT data as well as PET images constructed using standard of care non-contrast EID-CT data in random order. Both raters will assess PET images subjectively regarding overall image quality using a five-point Likert scale. The rating will be defined as: (1) non-diagnostic - insufficient diagnostic confidence, (2) poor - low diagnostic confidence, (3) moderate - average diagnostic confidence; (4) good - high diagnostic confidence, and (5) excellent - full diagnostic confidence. | Other | PET CT scan |
| PET CTTo compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review. | Other | PCD-CT |
Primary outcome
improve PET image w/ non-contrast PCD-CT data
Time frame: 2 years
We expect that the subjective PET image quality will be improved by using non-contrast PCD-CT data for construction resulting in higher diagnostic confidence; demonstrating a case for the integration of PCD-CT into standard of care clinical PET-CT imaging in the future. There will be no direct benefit to study participants and the outcome will not be directly reported to the treatment team or patient and will not impact treatment or care received.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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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.
Kevin Horn, PhD, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCD-CT and PET CT in people with Head and Neck Cancer (H&N), run by Medical University of South Carolina at 1 site 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 6 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: paused, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
improve PET image w/ non-contrast PCD-CT data (time frame: 2 years). 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 27 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.