NCT05240040

Brief 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 benefits of the therapy in order to formulate recommendation to other centers.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 23, 2026

Status Verified

February 1, 2022

Enrollment Period

5.8 years

First QC Date

April 3, 2019

Last Update Submit

March 19, 2026

Conditions

Intrahepatic CholangiocarcinomaMetastatic CancerMetastatic Liver CancerLiver Tumor

Keywords

Intrarterial glassRadiospheresLiver CancerIntrahepatic

Outcome Measures

Primary Outcomes (2)

  • review the outcomes of patients treated with radiospheres

    Patient survival

    January 2006 until April 2017

  • time to recurrence

    time to recurrence

    January 2006 until April 2017

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have the diagnosis of intrahepatic cholangiocarcinoma and were treated at MDMC .

You may qualify if:

  • 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

You may not qualify if:

  • Patients without the diagnosis of intrahepatic cholangiocarcinoma
  • Patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CholangiocarcinomaCarcinoma, HepatocellularNeoplasm MetastasisLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alejandro Mejia, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

February 15, 2022

Study Start

April 26, 2016

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 23, 2026

Record last verified: 2022-02

Locations

US(1)