Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04668872

Conditions

Colon Cancer Liver Metastasis

Colon Cancer

Adenocarcinoma of the Colon

Adenocarcinoma of the Rectum

Liver Metastasis Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Y90 TARE

PET/CT

PET/MRI

Study Details

Brief summary:

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.

Conditions

Colon Cancer Liver Metastasis

Colon Cancer

Adenocarcinoma of the Colon

Adenocarcinoma of the Rectum

Liver Metastasis Colon Cancer

Study ID

NCT04668872

Start date

Dec 7, 2020

Status verified date

Mar, 2026

Completion date

Dec 7, 2026

Anticipated

Primary completion date

Dec 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with colorectal cancer liver metastases

The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases.

Interventions

Y90 TARE

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.

PET/CT

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

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 outcome measure

  • Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours [ Time Frame: 72 hours after treatment ]
  • 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 ]

Central Contacts and Locations

Central contacts

Constantinos T Sofocleous, MD, PhD

212-639-3379sofoclec@mskcc.org

Assen Kirov, PhD

212-639-7126kirova@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Constantinos T Sofocleous, MD, PhD

212-639-3379

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-03-12.