HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
NCT06899152
Adenocarcinoma, Carcinoma
The Bronx, New York, United States
View Trial DetailsNCT Number: NCT07717437
The DRAGON registry aims to collect data on combined portal and hepatic vein embolization (PVE/HVE) for liver tumors, a technique expected to enhance liver regeneration compared to standard PVE. This collaborative registry focuses on identifying associations between baseline clinical/imaging parameters, clinical outcomes, and safety for patients undergoing PVE/HVE.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Monash Medical Centre, Clayton, Victoria, Australia
Retrospective and prospective
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Time frame: From enrolment until 5 year follow up
Time frame: Perioperative
The number of complications occurring during liver embolization (e.g., spill to the future liver remnant).
Time frame: 3 weeks after the embolization
Volumetric assessments are performed at baseline and three weeks after embolization. Changes in FLR volume will be standardized (sFLR) by calculating the ratio of the FLR to the Standardized Total Liver Volume (sTLV) using the Vauthey formula. The DH will be calculated as the percentage point difference in sFLR volume between baseline and three weeks after embolization. The KGR will then be derived from the DH, quantifying the weekly percentage volume increase observed between these measurements.
Time frame: Three weeks after the embolization
The Functional Growth Rate reflects the rate at which FLR function increases after embolization, as measured by hepatobiliary scintigraphy. FLR function is expressed in %/min/m2 at baseline and three weeks after embolization. The functional degree of hypertrophy (FDH-function) is the percentage point difference in FLR function between these time points, and the FGR is calculated by dividing the DH-function by the number of weeks elapsed.
Time frame: 90 days post-embolization / post-resection
90-day survival is defined as the proportion of patients alive at 90 days after liver embolization, serving as a standard measure of short-term postoperative outcome and surgical safety.
Time frame: Perioperative
The number of complications occurring during liver surgery (e.g., excessive blood loss and vascular or biliary injury).
Time frame: 90 days
90-day survival is defined as the proportion of patients alive at 90 days after liver surgery, serving as a standard measure of short-term postoperative outcome and surgical safety.
Time frame: Until MDT decision on resection (yes/no), approximately 3-6 weeks after the embolization
The clinical resection rate is defined as the proportion of patients who undergo liver resection among those who started embolization.
Time frame: Approximately 3-6 weeks after the embolization
This outcome measure captures the proportion of patients in whom the FLR fails to reach a sufficient volume or function after the initial embolization procedure, and who therefore undergo an additional salvage intervention (e.g., repeat or completion embolization) to further promote FLR growth before resection can be considered
Time frame: Until five years after the embolization/resection
The proportion of patients who develop disease recurrence (locoregional or distant) during follow-up after liver resection.
Time frame: Until five years after the embolization/resection
The number of additional oncological interventions (e.g., chemotherapy, repeat liver resection, ablation, radiotherapy) administered to patients during follow-up
Contact information is provided by the study sponsor or research team.
Maastricht University Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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