Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06753903

Role of Photon Counting CT in Detecting Liver Metastatis From Colorectal Cancer

Colorectal cancer is the first leading cause of cancer death in men and second in women. Its incidence rates also increased by 1%-2% annually in young adults (ages <55 years). The liver is the most common site of colorectal cancer metastasis, with approximately 25% 50% of patients developing liver metastases during the disease. Maximising resection of liver metastasis using all available techniques remains a key objective and provides the best chance of long-term survival and cure. For unresectable patients, optimal systemic and locoregional chemotherapeutic, biological and radiotherapeutic treatments improve survival, and may convert initially unresectable patients to operability. Computed Tomography is currently the modality of choice for patients staging and restaging for high spatial resolution providing accurate delineation of lesion, vascular structure and relation with surrounding structure. The portal venous phase (approximately 60-70 s after administration of contrast agent) is the most reliable phase for detection of liver metastasis with a detection rate of 85% with lower performance for lesion <1 cm which are interpreted as too small to characterize. Compared to computed tomography, MRI has superior soft tissue contrast and the possibly of a multiparametric characterization of lesion thanks to the evaluation of diffusivity and the uptake of hepatospecific contrast media, resulting in higher accuracy also for lesion smaller than < 10 mm. Photon-counting detector computed tomography (PCD-CT), used as standard clinical practice, by employing a reduced radiation dose, allows the acquisition of ultra-high resolution images (up to 169 microns) and spectral information, with a high detection rate of liver metastases and their characterization.

Therefore, aim of the present study is to evaluate the value of PCD-CT in the detection of liver metastasis from colorectal cancer in comparison to MRI as reference standard.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Antonio Esposito

CONTACT

02 2643 6102

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult (>18 years)
  • non- biopsy-proven colon/colorectal carcinoma
  • CT performed on a PCD-CT
  • MRI with multiparametric protocol and hepatospecific contrast media

Exclusion criteria

  • pregnancy and breastfeeding
  • CT exam performed on a scan different from PCD-CT
  • absence of multiparametric MRI
  • MRI with non hepatospecific contrast agent
  • Absent informed consent signed

Treatment and study plan

PCD-CT

Procedure

Photon-counting detector computed tomography

Primary outcomes

  1. PCD-CT predictor of response to treatment in patients candidate to chemotherapy

    Time frame: 3 years

  2. The non-inferiority of PCD-CT compared to MRI in identifying liver metastases from colorectal cancer

    Time frame: 3 years

Secondary outcomes

  1. the utility of machine learning-driven texture analysis in detecting prognostic imaging biomarkers for liver metastasis survival, with predictive performance measured by the concordance index.

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Esposito, MD

CONTACT

[email protected]

0226436102

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: PCDCRC-D34H

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 31, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.