RECRUITING

Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.

Official Title

Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study

Quick Facts

Study Start:2020-12-07
Study Completion:2024-12-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04668872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age ≥ 18 years
  2. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  3. * histologically confirmed primary adenocarcinoma of the colon or rectum
  4. * CLM considered unresectable or not amenable to percutaneous ablation
  5. * existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.
  6. * adequate blood cell counts (WBC \> 1.5 x 109/L, platelet count \> 50 x 109/L)
  7. * adequate renal function (creatinine \< 1.5 mg/dL)
  8. * total bilirubin level ≤ 1.5 mg/dL
  1. * prior hepatic radiotherapy (The lesion / lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions / lobes in the liver may be evaluated under the protocol)
  2. * severe cirrhosis
  3. * severe portal hypertension
  4. * uncorrectable flow to the gastrointestinal tract and/or \>30 Gy (or \>50 Gy in multiple sessions) radiation absorbed dose to the lungs

Contacts and Locations

Study Contact

Constantinos T Sofocleous, MD, PhD
CONTACT
212-639-3379
sofoclec@mskcc.org
Assen Kirov, PhD
CONTACT
212-639-7126
kirova@mskcc.org

Principal Investigator

Constantinos T Sofocleous, MD, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Constantinos T Sofocleous, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-07
Study Completion Date2024-12-07

Study Record Updates

Study Start Date2020-12-07
Study Completion Date2024-12-07

Terms related to this study

Keywords Provided by Researchers

  • colorectal liver metastases
  • transarterial radioembolization
  • Y90 TARE
  • Colon Cancer Liver Metastasis
  • Colon Cancer
  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Colorectal Cancer
  • Memorial Sloan Kettering Cancer Center
  • 20-355

Additional Relevant MeSH Terms

  • Colon Cancer Liver Metastasis
  • Colon Cancer
  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Liver Metastasis Colon Cancer
  • Colorectal Cancer