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NCT Number: NCT06774690

Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study

The goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (IAT) for primary liver cancer.

Intra arterial therapies are radiologic procedures that block liver cancer blood supply.

The researchers will collect the data of participants located in the Radiology department in "IRCCS Azienda Ospedaliera Universitaria" Hospital in Bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Cristina Mosconi, MD

CONTACT

[email protected]

0039 3498496325

About this study

This study is non profit, observational, retrospective, prospective and single institution.

The researchers will do a retrospective and prospective data collection and analyze the results. They will examine the radiological images (CT scan and RM) to assess the type and size of the cancer, track how the disease responds to treatments, identify possible complications.

There are no drugs involved and all the intra arterial therapies are performed within the routine clinical-care path.

  • For the retrospective phase the researchers will analyze radiological image of the participants that received a intra arterial therapy from the 1st of January 2009. It's expected to enroll around 2000 participants.
  • For the prospective phase the researchers will enroll for 5 years eligible participants that will receive a intra arterial therapy. Participants will go through a follow up every three months for the duration of the whole study. It is expected to enroll around 1300 participants.

Who can participate

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

Inclusion criteria

  • diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:
  • Trans-arterial embolization (TAE),
  • Transarterial chemoembolization (TACE),
  • Transarterial radioembolization (TARE)
  • Drug-eluting beads chemoembolization (DEB-TACE)
  • Age over 18
  • To give informed consent

Exclusion criteria

  • shunt of gastro intestinal arteries that cannot be embolized
  • metastasis spread outside of the liver
  • liver failure

Treatment and study plan

Primary outcomes

  1. Type and size of the injury

    Time frame: From enrollment to the end of treatment at 9 years

    Type and size of the injury

  2. Radiological response to therapy

    Time frame: From enrollment to the end of treatment at 9 years

    Radiological response to therapy

  3. Post treatment complications

    Time frame: From enrollment to the end of treatment at 9 years

    Post treatment complications

Study contacts

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

Cristina Mosconi, MD

CONTACT

[email protected]

0039 3498496325

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

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.

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