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New treatment option for Metastases
Official title Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
ClinicalTrials.gov ID: NCT05195710
What this study is testing
What is Yttrium-90 (Y-90) resin microspheres?
Yttrium-90 (Y-90) resin microspheres is an investigational medicine, being studied as a potential treatment for metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
- Phase 1: an early, usually small safety 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
- Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as...
- Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major...
- Received at least four cycles (or two months) of chemotherapy
- Willing, able and mentally competent to provide written informed consent
- Medically and physically operable as determined by the surgeon
You likely can't join if
- Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable"...
- Projected sFLR before Y-90 of \<20% (starting with sFLR that is unrealistic for improvement to ≥30%)
- Performance status limitations (Karnofsky \ 1)
- Portal hypertension and/or cirrhosis
- Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease)
- CEA \>200 after 4 cycles of chemotherapy upon restaging visit
See the full eligibility criteria
- Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team
- Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a...
- Received at least four cycles (or two months) of chemotherapy
- Willing, able and mentally competent to provide written informed consent
- Medically and physically operable as determined by the surgeon
- Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy...
- Projected sFLR before Y-90 of \<20% (starting with sFLR that is unrealistic for improvement to ≥30%)
- Performance status limitations (Karnofsky \ 1)
- Portal hypertension and/or cirrhosis
- Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease)
- CEA \>200 after 4 cycles of chemotherapy upon restaging visit
- Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection
- Platelet count \<100,000/µL
- Albumin \<3.5 g/dl
- Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
- Pregnant or breast-feeding patient
- Other medical or clinical contraindications to liver surgery
- Non-English-speaking participants
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.