Clinical trial NCT04668872: Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
Official title: Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colon Cancer Liver Metastasis
Colon Cancer
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Liver Metastasis Colon Cancer
Colorectal Cancer
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours
timeFrame: 72 hours after treatment
measure: Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days
timeFrame: Between 14-21 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Constantinos T Sofocleous, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: