Status:
RECRUITING
Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Colon Cancer Liver Metastasis
Colon Cancer
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 7 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04668872
Start Date
December 7 2020
End Date
December 7 2026
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065