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NCT05240040 Clinical Trial

Treat Primary and Metastatic Liver Tumors

Metastatic Cancer Clinical Trial

Official title:
Radioembolization to Treat Primary and Metastatic Liver Tumors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05240040
Other study ID # 029.HPB.2016.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 26, 2016
Est. completion date May 2022

Study information
Verified date February 2022
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date May 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients without the diagnosis of intrahepatic cholangiocarcinoma - Patients under 18 years of age

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary review the outcomes of patients treated with radiospheres Patient survival January 2006 until April 2017
Primary time to recurrence time to recurrence January 2006 until April 2017
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