Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

  • STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    20
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 27 April 2022

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.

Details
Condition Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastasis Colon Cancer, Colorectal Cancer
Treatment PET/CT, PET/MRI, Y90 TARE
Clinical Study IdentifierNCT04668872
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
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
severe cirrhosis
under the protocol)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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