Exploring Photon-Counting CT for Enhanced Target Delineation and Dose Accuracy in Personalized Radiotherapy - ANTHEM

NCT07098247 | Recruiting

• 1 other identifier: RAD4/RT_ANTHEM
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  day 1 (day of simulation TC)

Secondary Outcomes (1)

• Enhanced dose calculation precision, particularly for proton therapy

  Day 1 (day of simulation TC)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ≥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.

You may not qualify if:

• \- 18 years old patients

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marta Scorsettti, MD, radiation oncologist

  Humanitas University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research study coordinator

CONTACT

+39 0282247026; laura.bonavita@humanitas.it

Research nurse

CONTACT

+39 0282248513; barbara.alt@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: August 1, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

IT (1)