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New treatment option for Liver Metastases
Official title Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
ClinicalTrials.gov ID: NCT04143516
What this study is testing
- What it's testing
- This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of liver metastases from various primary tumors
- Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
- Lesions of ≤3 cm in maximum diameter
- At least one FDG-avid lesion to be treated\ \ \
- INR \< 1.5\
You likely can't join if
- Age \< 18
- Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as...
- INR \> 1.5 that cannot be corrected with fresh frozen plasma \ \
- Platelet count of \<50,000 that cannot be corrected with transfusion
- More than 3 tumors in the liver
- More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
See the full eligibility criteria
- Diagnosis of liver metastases from various primary tumors
- Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
- Lesions of ≤3 cm in maximum diameter
- At least one FDG-avid lesion to be treated\ \ \
- INR \< 1.5\
- Platelet count ≥ 50,000
- Age \< 18
- Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection
- INR \> 1.5 that cannot be corrected with fresh frozen plasma \ \
- Platelet count of \<50,000 that cannot be corrected with transfusion
- More than 3 tumors in the liver
- More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
- Presence of any peritoneal Carcinomatosis
- For patients on Coumadin, general clinical guidelines for IR ablation will be followed.
- For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.