NCT04668872 Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
| NCT ID | NCT04668872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Colon Cancer Liver Metastasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2020-12-07 |
| Primary Completion | 2026-12-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2020-12-07 with a primary completion date of 2026-12-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Constantinos T Sofocleous, MD, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04668872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Cancer Liver Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04668872 currently recruiting?
Yes, NCT04668872 is actively recruiting participants. Contact the research team at sofoclec@mskcc.org for enrollment information.
Where is the NCT04668872 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04668872 clinical trial?
NCT04668872 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Constantinos T Sofocleous, MD, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.