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

NCT06753903 | Recruiting

• 1 other identifier: PCDCRC-D34H
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

  3 years

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

  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.

  3 years

Interventions

PCD-CT PROCEDURE

Photon-counting detector computed tomography

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with colorectal cancer and liver metastasis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (6)

• Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.

  PMID: 38230766 BACKGROUND

• Martin J, Petrillo A, Smyth EC, Shaida N, Khwaja S, Cheow HK, Duckworth A, Heister P, Praseedom R, Jah A, Balakrishnan A, Harper S, Liau S, Kosmoliaptsis V, Huguet E. Colorectal liver metastases: Current management and future perspectives. World J Clin Oncol. 2020 Oct 24;11(10):761-808. doi: 10.5306/wjco.v11.i10.761.

  PMID: 33200074 BACKGROUND

• Soyer P, Poccard M, Boudiaf M, Abitbol M, Hamzi L, Panis Y, Valleur P, Rymer R. Detection of hypovascular hepatic metastases at triple-phase helical CT: sensitivity of phases and comparison with surgical and histopathologic findings. Radiology. 2004 May;231(2):413-20. doi: 10.1148/radiol.2312021639. Epub 2004 Mar 24.

  PMID: 15044747 BACKGROUND

• Sahani DV, Bajwa MA, Andrabi Y, Bajpai S, Cusack JC. Current status of imaging and emerging techniques to evaluate liver metastases from colorectal carcinoma. Ann Surg. 2014 May;259(5):861-72. doi: 10.1097/SLA.0000000000000525.

  PMID: 24509207 BACKGROUND

• Vilgrain V, Esvan M, Ronot M, Caumont-Prim A, Aube C, Chatellier G. A meta-analysis of diffusion-weighted and gadoxetic acid-enhanced MR imaging for the detection of liver metastases. Eur Radiol. 2016 Dec;26(12):4595-4615. doi: 10.1007/s00330-016-4250-5. Epub 2016 Feb 16.

  PMID: 26883327 BACKGROUND

• Wang Q, Shi G, Qi X, Fan X, Wang L. Quantitative analysis of the dual-energy CT virtual spectral curve for focal liver lesions characterization. Eur J Radiol. 2014 Oct;83(10):1759-64. doi: 10.1016/j.ejrad.2014.07.009. Epub 2014 Jul 22.

  PMID: 25088350 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Antonio Esposito, MD

CONTACT

0226436102; esposito.antonio@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): March 24, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-12

Locations

IT (1)