Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
Recruiting · NCT04668872 · Observational (researchers observe without assigning treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
PET/CTPET/MRIY90 TARE
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- Memorial Sloan Kettering Cancer Center - New York, New York, United States