Clinical trial · Interventional
Improving CBCT for Liver IG-SBRT Using Gadoxetate Disodium
Improving Cone-beam Computed Tomography for Image Guided Stereotactic Body Radiation Therapy of the Liver Using Gadoxetate Disodium
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not approved
Summary
Brief summary (as posted)
This is a feasibility study requiring only three patients to serve as a proof of concept that gadoxetate disodium (a liver specific contrast agent) can be used to improve images taken just before liver SBRT treatments. The hypothesis of this research is that if gadoxetate disodium improves image quality at the time of treatment, then it can be used for image guided radiotherapy (IGRT). Image guidance is the procedure where the 3D CT image that is used to plan a radiotherapy treatment, is aligned to a 3D image taken just before treatment. The better the alignment, the more accurate the treatment, which is crucial for high dose treatments such as SBRT. This research is important for two main reasons. First, it is much less invasive than the standard of care which involves surgically implanting markers in the liver that can move over time. The benefit to harm ratio for surgery, compared to an injection, is much more dramatic. Furthermore, not all patients are surgical candidates, and therefore in those cases radiation oncologists must prescribed a larger area to treat to ensure that none of the cancerous region is missed. The drawback to this method is the irradiation of more normal tissue than necessary, which although deemed to have a greater benefit than harm, is not ideal. Secondly, this research has strong implications in the field of radiation oncology to move towards patient oriented radiotherapy treatments. If successful, radiation treatment to the liver could be performed in less treatments because of the confidence given to radiation oncologists of the cancer location; knowing exactly the healthy liver regions to avoid.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primovist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants receiving Primovist
- description
- Because this is a proof of concept study, only one arm will be considered which is the patients that receive the one time contrast injection prior to their first treatment. The intervention is that although this drug is approved, an off label dosing regiment is being used to improve a separate imaging modality than what it was approved for. Based on preliminary phantom experiments and toxicity results in the literature, four times the dose was deemed safe and required to use for CBCT.
- interventionNames
- Drug: Primovist
Primary outcomes (1)
- measure
- Improved image quality after injection as determined by contrast-to-background calculation and expert observation.
- timeFrame
- 12 months
- description
- Images will be read by a radiologist and radiation oncologist to qualitatively assess whether or not image enhancement occurred. This will be compared to the quantitative standard of calculating the amount of contrast in the region that is to be enhanced, compared to the surrounding normal tissue (background). Adequate enhancement will be taken as contrast-to-background ratio greater than 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and over * Not suitable for surgery or radio-frequency ablation (RFA). * Histologic confirmation of cancer diagnosis and/or histologic confirmation of liver malignancy * Meets criteria for oligometastasis (not more than 5 metastases in total, none larger than 5cm in diameter, no more than 3 in any one organ). * Child-Pugh: A * \> 700cc uninvolved liver * No limitation on the actual size of the tumor providing organ at risk (OAR) dose constraints can be met * ECOG performance status 0-2 * Acceptable kidney and liver function : (AST/ALT/GGT, alkaline phosphate, total bilirubin, albumin), normal serum creatinine or Creatinine clearance \> 60mL/min * Life expectancy \> 6 months * No chemotherapy within 4 weeks * Recurrence at the site of prior liver resection Exclusion Criteria: * Age less than 18 years * Previous diagnosis of chronic sever renal insufficiency * Previous diagnosis of acute renal failure * Previous diagnosis of acute kidney injury * Patients with biliary obstruction * Impaired liver enzymes (\>6x ULN) * Platelets \< 50 000 * \< 700cc of normal liver * Ongoing or planned chemotherapy * Progressing extra-hepatic disease * History of active hepatitis * Significant comorbidities within previous 6 months (unstable angina, MI, ascites, coagulopathy) * Prior radiotherapy to site/sites of progressive disease
References
Publications (0)
Data not yet available