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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The patients will be identified and recruited from the existing patient population in the Interventional Oncology/Radiology Service of the Department of Radiology at Memorial Sloan-Kettering Cancer Center (MSKCC). The patients will be presented with a study consent form and an explanation of any concerns they may have by the Principal Investigator or research team (i.e. Co-Investigators and consenting professionals).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Participants with colorectal cancer liver metastases3 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
72 hours after treatment
2

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

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.

Time frame
Between 14-21 days after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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