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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how radioembolization, a radiation treatment, changes tumor cells. It collects small tumor samples after treatment from adults with colon or rectal cancer that has spread to the liver.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • A tissue test confirms adenocarcinoma, a type of cancer, that started in the colon or rectum.
  • Liver tumors cannot be removed by surgery or cannot be destroyed with treatment through a needle. For the 90Y radiation segmentectomy group, surgery or heat-based treatment must not be options.
  • Have a tumor sample from a routine biopsy within 42 days before treatment, or have a medical need for a biopsy at treatment under the center’s rules for cancer that is getting worse.
  • White blood cell count above 1.5 × 10⁹/L and platelet count above 50 × 10⁹/L. Platelets help blood clot.
  • Kidney blood test: creatinine below 1.5 mg/dL. Liver blood test: total bilirubin at or below 1.5 mg/dL.
  • Cancer mainly in the liver may qualify even if it has spread to up to 5 places outside the liver, if those areas are stable or controlled by chemotherapy.

Who can't join

  • Past radiation to the liver tumor or liver section being treated. Areas that have not had radiation may still be considered.
  • Severe cirrhosis, which is scarring of the liver.
  • Severe portal hypertension, which is high pressure in the vein carrying blood to the liver.
  • Blood flow that could carry treatment to the stomach or intestines and cannot be corrected.
  • An absorbed radiation dose to the lungs above 30 Gy in one session or above 50 Gy over several sessions. Gy is a unit of radiation dose.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY