CancerRAD4/RT_ANTHEMNCT07098247
Exploring Photon-Counting CT for Enhanced Target Delineation and Dose Accuracy in Personalized Radiotherapy - ANTHEM
An observational study of Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Radiotherapy remains a cornerstone of oncology care, particularly for rare or orphan cancers and chronic oncologic and rare non oncologic conditions, where precision and individualized treatment planning are necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2025to May 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing radiotherapy for orphan cancers, chronic conditions, and anatomically complex regions such as brain, head and neck, thorax, liver, pancreas and pelvis.
Who may be able to join
- ≥18 years old patients
- tumors located in challenging anatomical regions (brain, head and neck, liver, pancreas prostate), or Cardiac disease requiring RT by photon or proton at our Institution.
Who cannot join
- 18 years old patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089
About this study
Radiotherapy remains a cornerstone of oncology care, particularly for rare or orphan cancers and chronic oncologic and rare non oncologic conditions, where precision and individualized treatment planning are necessary. Advances in imaging technologies are crucial to overcome the challenges posed by these cases, especially in achieving accurate tumor delineation and dose delivery. Photon-counting CT (PCCT) represents a transformative step forward in imaging technology. Unlike conventional energy-integrating CT, PCCT offers a) superior spatial resolution, enabling clearer visualization of tumor margins and fine anatomical structures, b) enhanced tissue characterization, allowing better differentiation between tumor tissues and normal tissue; c) spectral imaging capabilities, facilitating improved dose calculations. These attributes are particularly advantageous in high-precision radiotherapy techniques, such as stereotactic body radiotherapy (SBRT) or proton therapy, where small errors in target delineation or dose delivery can significantly impact treatment outcomes. However, very limited data reporting the clinical use of PCCT for RT planning are available.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with cancer | 500 patients undergoing radiotherapy for orphan cancers, chronic conditions, and anatomically complex regions such as brain, head and neck, thorax, liver, pancreas and pelvis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve RT target delineation accuracy and differentiation of organs-at-risk (OARs).
During the simulation, the investigator will evaluate the image quality obtained from photon-counting TC imaging compared to conventional imaging techniques, and assess how this improved imaging could enhance radiotherapy treatment planning. The data will be evaluated by indicative scores of imaging quality and treatement planning.
minimum scale value is one and indicates a poor quality of the imaging - maximum scale value is five and indicates excellent image quality
Measured: day 1 (day of simulation TC)
Secondary outcomes (1)
Enhanced dose calculation precision, particularly for proton therapy
During the simulation, the investigator will evaluate the image quality obtained from photon-counting TC imaging compared to conventional imaging techniques, and assess how this improved imaging could enhance radiotherapy treatment planning. The data will be evaluated by indicative scores of imaging quality and treatement planning.
minimum scale value is one and indicates a poor quality of the imaging - maximum scale value is five and indicates excellent image quality
Measured: Day 1 (day of simulation TC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start4 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Scorsettti, MD, radiation oncologist, Principal investigator, Humanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098247
- Sponsor's protocol ID
- RAD4/RT_ANTHEM
- Acronym
- RAD4/RT_ANTHEM
- Status last verified
- Jul 2025
- First submitted
- 22 Apr 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Photon-Counting CT for Enhanced Target Delineation and Dose Accuracy in Personalized Radiotherapy - ANTHEM
- ClinicalTrials.gov ID
- NCT07098247
- Acronym / sponsor ID
- RAD4/RT_ANTHEM / RAD4/RT_ANTHEM
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 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.
Radiotherapy remains a cornerstone of oncology care, particularly for rare or orphan cancers and chronic oncologic and rare non oncologic conditions, where precision and individualized treatment planning are necessary. Advances in imaging technologies are crucial to overcome the challenges posed by these cases, especially in achieving accurate tumor delineation and dose delivery. Photon-counting CT (PCCT) represents a transformative step forward in imaging technology. Unlike conventional energy-integrating CT, PCCT offers a) superior spatial resolution, enabling clearer visualization of tumor margins and fine anatomical structures, b) enhanced tissue characterization, allowing better differentiation between tumor tissues and normal tissue; c) spectral imaging capabilities, facilitating improved dose calculations. These attributes are particularly advantageous in high-precision radiotherapy techniques, such as stereotactic body radiotherapy (SBRT) or proton therapy, where small errors in target delineation or dose delivery can significantly impact treatment outcomes. However, very limited data reporting the clinical use of PCCT for RT planning are available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with cancer | – | –500 patients undergoing radiotherapy for orphan cancers, chronic conditions, and anatomically complex regions such as brain, head and neck, thorax, liver, pancreas and pelvis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing radiotherapy for orphan cancers, chronic conditions, and anatomically complex regions such as brain, head and neck, thorax, liver, pancreas and pelvis.
Key inclusion criteria (2 listed)
- ≥18 years old patients
- tumors located in challenging anatomical regions (brain, head and neck, liver, pancreas prostate), or Cardiac disease requiring RT by photon or proton at our Institution.
Key exclusion criteria (1 listed)
- 18 years old patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improve RT target delineation accuracy and differentiation of organs-at-risk (OARs).
Time frame: day 1 (day of simulation TC)
During the simulation, the investigator will evaluate the image quality obtained from photon-counting TC imaging compared to conventional imaging techniques, and assess how this improved imaging could enhance radiotherapy treatment planning. The data will be evaluated by indicative scores of imaging quality and treatement planning. minimum scale value is one and indicates a poor quality of the imaging - maximum scale value is five and indicates excellent image quality
1 secondary outcome
Enhanced dose calculation precision, particularly for proton therapy
Time frame: Day 1 (day of simulation TC)
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 1 Aug 2025.
Related trials for Cancer
Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
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.
Marta Scorsettti, MD, radiation oncologist principal investigator
Humanitas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
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 1 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 1 Aug 2025. 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 Italy. 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 Research study coordinator (+39 0282247026, laura.bonavita@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve RT target delineation accuracy and differentiation of organs-at-risk (OARs). (time frame: day 1 (day of simulation TC)). 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 1 Aug 2025.