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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Colon Cancer; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Colon Cancer Liver Metastasis; Liver Metastasis Colon Cancer; Colorectal Cancer

Treatments: Diagnostic Test: PET/CT; Diagnostic Test: PET/MRI; Radiation: Y90 TARE

Study type: Observational

Funder types: Other

Identifiers

NCT04668872

20-355

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Participants with colorectal cancer liver metastases

Description:

The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases.

Treatment:

Radiation: Y90 TARE

Diagnostic Test: PET/MRI

Diagnostic Test: PET/CT