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AzTrials

Colorectal CancerPCDCRC-D34HNCT06753903

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

An observational study of Colorectal Cancer, run by IRCCS San Raffaele at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Colorectal Cancer
What is being tested?
PCD-CT
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteItaly
Study dates
24 Mar 2025to 24 Mar 2028
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 to 100 years
  • All sexes
  • Adult, Older adult

Study population: 100 patients with colorectal cancer and liver metastasis

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio Esposito, MD contact

0226436102

esposito.antonio@hsr.it

Italy1 site, 1 recruiting

  • IRCCS San Raffaele

    Milan, 20132

    Antonio Esposito, 02 2643 6102

    Recruiting

Other trials in Italy

About this study

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.

Being tested
PCD-CT
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCD-CTProcedure or surgery

    Photon-counting detector computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years

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

    Measured: 3 years

Secondary outcomes (1)

  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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start24 Mar 2025
  3. Primary completion24 Mar 2028 (estimated)
  4. Study completion24 Mar 2028 (estimated)

Resources

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
Other
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753903
Sponsor's protocol ID
PCDCRC-D34H
Acronym
PCDCRC-D34H
Status last verified
Dec 2025
First submitted
23 Dec 2024
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38230766

  • 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.

    PubMed 33200074

  • 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.

    PubMed 15044747

  • 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.

    PubMed 24509207

  • 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.

    PubMed 26883327

  • 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.

    PubMed 25088350

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by IRCCS San Raffaele 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 4 inclusion and 5 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 15 Jan 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 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 Antonio Esposito, MD (0226436102, esposito.antonio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PCD-CT predictor of response to treatment in patients candidate to chemotherapy (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06753903, which also lists 6 linked publications.

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 15 Jan 2026.

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