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NCT04668872Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
9 Dec 2020
Start date
7 Dec 2020
Primary completion date
7 Dec 2026
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT04668872

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 7 Dec 2020 to the primary completion date, 7 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • severe portal hypertension
  • uncorrectable flow to the gastrointestinal tract and/or \>30 Gy (or \>50 Gy in multiple sessions) radiation absorbed dose to the lungs
    • All patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.

Other

  • Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:
  • severe cirrhosis

Who the study is looking for

  • age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • histologically confirmed primary adenocarcinoma of the colon or rectum
  • CLM considered unresectable or not amenable to percutaneous ablation
  • 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.
  • adequate blood cell counts (WBC \> 1.5 x 109/L, platelet count \> 50 x 109/L)
  • adequate renal function (creatinine \< 1.5 mg/dL)
  • total bilirubin level ≤ 1.5 mg/dL
    • Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:
  • patients not amenable to surgery or thermal ablation

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.