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NCT Number: NCT04668872

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Constantinos T Sofocleous, MD, PhD

CONTACT

212-639-3379

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

A. patients not amenable to surgery or thermal ablation

Exclusion criteria

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

  • 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)
  • severe cirrhosis
  • 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.

Treatment and study plan

Y90 TARE

Radiation

Y90 TARE will be performed as standard of care (SOC)/clinically indicated: 1) in a lobar or sub-lobar fashion (depending on tumor involvement and location; also targeting the tumor as selective as possible and sparing as much as possible of non-involved liver parenchyma), for participants with extensive bilobar disease or 2) in a radiation segmentectomy approach, intending to deliver 190 Gy radiation dose to target tumor: for patients with limited liver metastatic disease, not amenable for surgery or ablation.

Other names: 90Y transarterial radioembolization

PET/CT

Diagnostic Test

Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.

PET/MRI

Diagnostic Test

Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.

Primary outcomes

  1. Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours

    Time frame: 72 hours after treatment

    Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma.

  2. Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days

    Time frame: Between 14-21 days after treatment

    Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma.

Study contacts

Contact information is provided by the study sponsor or research team.

Assen Kirov, PhD

CONTACT

[email protected]

212-639-7126

Constantinos T Sofocleous, MD, PhD

CONTACT

[email protected]

212-639-3379

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2020
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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