A Study to See if we Can Predict How Your Liver Tumor or Liver Metastases Will Respond to Trans-Arterial Embolization (TAE)
|ClinicalTrials.gov Identifier: NCT02772575|
Recruitment Status : Withdrawn
First Posted : May 13, 2016
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment|
|Liver Cancer Liver Metastases||Procedure: Hepatic trans-arterial embolization (TAE) Device: MRI/CT scan Procedure: biopsy Other: blood draw|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||January 2017|
patients with primary liver or liver metastases
A biopsy will be performed as standard of care either at time of Hepatic trans-arterial embolization (TAE) or within 4 months prior to TAE. TAE is a standard of care procedure. Within 8 weeks of TAE, patient will have a clinic visit which will include medical history, physical examination, vital signs, EKG (if one is not available), and ECOG assessment. Additionally a dedicated liver CT or MR will be obtained as well as standard of care labs. IMPACT blood test will be performed at the time of any of the standard of care labs. As IMPACT platform at MSKCC continually evolves to include more genes, we will use the platform available at the time of initiation of the protocol, therefore all patients will be subjected to the same platform. RNA-seq has been demonstrated to be superior in detecting low abundance transcripts, demonstrating a broader dynamic range, and detecting different isoforms and genetic variants.
Procedure: Hepatic trans-arterial embolization (TAE)
Device: MRI/CT scan
Other: blood draw
- response [ Time Frame: within 4 weeks ]
Response will be categorized using standard mRECIST criteria. Tumor response will be catalogued as follows:
Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Stable Disease (SD): Any cases that do not qualify for either partial response or progressive disease. Progressive Disease (PD): An increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the of viable (enhancing) target lesions recorded since treatment started.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772575
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Etay Ziv, MD, PhD||Memorial Sloan Kettering Cancer Center|