Intrahepatic CholangiocarcinomaNCT05240040
Treat Primary and Metastatic Liver Tumors
An observational study of Intrahepatic Cholangiocarcinoma and Liver Tumor, run by Methodist Health System.
Trial summary
The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Liver Tumor, Metastatic Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2016to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have the diagnosis of intrahepatic cholangiocarcinoma and were treated at MDMC .
Who may be able to join
- Patients with the diagnosis of intrahepatic cholangiocarcinoma from January 2006 until April 2017 at Methodist Dallas Medical Center (MDMC)
- Patients 18 years old or older
Who cannot join
- Patients without the diagnosis of intrahepatic cholangiocarcinoma
- Patients under 18 years of age
About this study
Official title: Radioembolization to Treat Primary and Metastatic Liver Tumors
The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.
Read the detailed description
A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means.
Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.
- Keywords
- Intrarterial glass, Radiospheres, Liver Cancer, Intrahepatic
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular, Neoplasm Metastasis, Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
review the outcomes of patients treated with radiospheres
Patient survival
Measured: January 2006 until April 2017
time to recurrence
time to recurrence
Measured: January 2006 until April 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start26 Apr 2016
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: Resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240040
- Sponsor's protocol ID
- 029.HPB.2016.D
- Status last verified
- Feb 2022
- First submitted
- 3 Apr 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioembolization to Treat Primary and Metastatic Liver Tumors
- ClinicalTrials.gov ID
- NCT05240040
- Acronym / sponsor ID
- 029.HPB.2016.D
- Keywords
- Intrarterial glass, Radiospheres, Liver Cancer, Intrahepatic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.
Detailed description
A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means.
Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have the diagnosis of intrahepatic cholangiocarcinoma and were treated at MDMC .
Key inclusion criteria (2 listed)
- Patients with the diagnosis of intrahepatic cholangiocarcinoma from January 2006 until April 2017 at Methodist Dallas Medical Center (MDMC)
- Patients 18 years old or older
Key exclusion criteria (2 listed)
- Patients without the diagnosis of intrahepatic cholangiocarcinoma
- Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
review the outcomes of patients treated with radiospheres
Time frame: January 2006 until April 2017
Patient survival
time to recurrence
Time frame: January 2006 until April 2017
time to recurrence
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
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REGULUS: MRI-guided Adaptive SABR for Liver Cancers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Mejia, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholangiocarcinoma and Liver Tumor, run by Methodist Health System.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
review the outcomes of patients treated with radiospheres (time frame: January 2006 until April 2017). 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?
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 23 Mar 2026.