Lung Neoplasm MalignantNCT06440616
Benefit of Spectral Information in Patients Suspected for Lung Cancer
A study testing Spectral CT images generated by a photon counting CT scanner in people with Lung Neoplasm Malignant, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Spectral CT images generated by a photon counting CT scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 24 May 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suspected of lung cancer refered to Copenhagen University Hospital as per the guidelines from the danish national health authorities from either the general practitioner or from the department of pulmonology.
- Informed consent
Who cannot join
- Patients who cannot tolerate intravenous iodinated contrast
- Already verified lung cancer from another institution
- Comorbidities that exclude the patient from receiving treatment
- Lack of reference standard in the form of either histology or follow-up
- Known extrapulmonary malignancy
- Technical limitations within the scans/reconstructions
- other
- Pr. the 29th of September included 433 participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Herlev
Herlev, Capital Region, 2730
Michael B Andersen, PhD, 38 68 38 68 ext. +45, michael.brun.andersen@region.dk
About this study
Official title: Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer
Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations.
As secondary aims we will compare conventional CT, CT + 18Flouro-deoxy-glucose (18F-FDG) positron emission tomography (PET) and PCCT + 18F-FDG PET for the tumor-node-metastasis (TNM) staging of lung cancer patients.
Read more
PCCT with and without spectral information to assess the need for additional work-up,TNM classification, and sensitivity/specificity for malignant lesions. Patients will be randomized for reading with or without spectral information available within a clinical setting. The clinical readings are performed as a structured reports of all significant findings. Including both malignant and benign findings. Furthermore, in case additional follow-up/work-up is needed based on the guidelines on incidental findings by the American College of Radiology (ACR), this will be reported as well. If lesions suspicious of pulmonary malignancy is present, a provisional TNM classification is provided based on the scan findings.
After 3 months, the patient record is reviewed where additional examinations that can be attributed to the PCCT scan are recorded. The financial impact is calculated by a health economist based on the findings. PET/CT, conventional CT and PCCT combined with PET will be assessed retrospectively for comparison. Endpoints are number of supplementary examinations and cost savings. Sensitivity and specificity for any malignant finding. The T, N and M stages are assessed separately as diagnostic measures by the McNemar's test with a reference standard from the Danish Lung cancer register. The number of malignant lesions will be determined by reviewing the patient records incl. pathology assessment if available 12 months after inclusion of the last patient.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Spectral CT images generated by a photon counting CT scanner
- Keywords
- Computed tomography, Spectral CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral CT images generated by a photon counting CT scannerDevice
The reading radiologist will in the experimental arm have access to spectral CT images in the form of low virtual monoenergetic images, virtual non-contrast images, iodine maps and effective atomic number. In the non-interventional arms the reading radiologist will only have access to conventional CT images.
| Study group | Role | What they receive |
|---|---|---|
| CT images without spectral information available | No intervention | Reported without access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings. |
| CT images with spectral information available | Experimental | Reported with access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings. Receives: Device: Spectral CT images generated by a photon counting CT scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follow up examinations
Determine the number of suggested follow-up examinations based on the initial CT scan to learn the significance of spectral information in a clinical setting.
Measured: Baseline
Secondary outcomes (2)
T, N, and M stage
Determine the accuracy of T, N, and M stage based on PCCT, conventional CT, PET/CT and PET/PCCT. Retrospective assessment 24 months after primary scan.
Measured: 24 months
Number of malignant lesions
Determine the number of found malignant lesions in each arm. Reference standard will be follow up or pathology within a minimum of one year of the scan. That means 12 months after the end of the inclusion period.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start24 May 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Brun Andersen, Copenhagen University Hospital at Herlev
- Investigators
- Michael B Andersen, PhD, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440616
- Sponsor's protocol ID
- H- 23045674
- Status last verified
- Mar 2026
- First submitted
- 27 May 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer
- ClinicalTrials.gov ID
- NCT06440616
- Acronym / sponsor ID
- H- 23045674
- Conditions
- Lung Neoplasm Malignant
- Keywords
- Computed tomography, Spectral CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Jun 2024 (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.
Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations.
As secondary aims we will compare conventional CT, CT + 18Flouro-deoxy-glucose (18F-FDG) positron emission tomography (PET) and PCCT + 18F-FDG PET for the tumor-node-metastasis (TNM) staging of lung cancer patients.
PCCT with and without spectral information to assess the need for additional work-up,TNM classification, and sensitivity/specificity for malignant lesions. Patients will be randomized for reading with or without spectral information available within a clinical setting. The clinical readings are performed as a structured reports of all significant findings. Including both malignant and benign findings. Furthermore, in case additional follow-up/work-up is needed based on the guidelines on incidental findings by the American College of Radiology (ACR), this will be reported as well. If lesions suspicious of pulmonary malignancy is present, a provisional TNM classification is provided based on the scan findings.
After 3 months, the patient record is reviewed where additional examinations that can be attributed to the PCCT scan are recorded. The financial impact is calculated by a health economist based on the findings. PET/CT, conventional CT and PCCT combined with PET will be assessed retrospectively for comparison. Endpoints are number of supplementary examinations and cost savings. Sensitivity and specificity for any malignant finding. The T, N and M stages are assessed separately as diagnostic measures by the McNemar's test with a reference standard from the Danish Lung cancer register. The number of malignant lesions will be determined by reviewing the patient records incl. pathology assessment if available 12 months after inclusion of the last patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT images without spectral information available | No intervention | –Reported without access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings. |
| CT images with spectral information available | Experimental | Device: Spectral CT images generated by a photon counting CT scannerReported with access to spectral information in a normal clinical practice. Supplemental examinations suggested as per the ACR white papers for incidental findings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suspected of lung cancer refered to Copenhagen University Hospital as per the guidelines from the danish national health authorities from either the general practitioner or from the department of pulmonology.
- Informed consent
Key exclusion criteria (8 listed)
- Patients who cannot tolerate intravenous iodinated contrast
- Already verified lung cancer from another institution
- Comorbidities that exclude the patient from receiving treatment
- Lack of reference standard in the form of either histology or follow-up
- Known extrapulmonary malignancy
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 |
|---|---|---|
| Spectral CT images generated by a photon counting CT scannerThe reading radiologist will in the experimental arm have access to spectral CT images in the form of low virtual monoenergetic images, virtual non-contrast images, iodine maps and effective atomic number. In the non-interventional arms the reading radiologist will only have access to conventional CT images. | Device | CT images with spectral information available |
Primary outcome
Number of follow up examinations
Time frame: Baseline
Determine the number of suggested follow-up examinations based on the initial CT scan to learn the significance of spectral information in a clinical setting.
2 secondary outcomes
T, N, and M stage
Time frame: 24 months
Number of malignant lesions
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Michael B Andersen, PhD principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral CT images generated by a photon counting CT scanner in people with Lung Neoplasm Malignant, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 8 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: looking for participants now, as of the sponsor's last update on 20 Mar 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Andersen, PhD (38 68 38 68 ext. +45, michael.brun.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of follow up examinations (time frame: Baseline). 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 20 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.