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Improving CBCT for Liver IG-SBRT Using Gadoxetate Disodium

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ClinicalTrials.gov Identifier: NCT03215355
Recruitment Status : Withdrawn (Not approved)
First Posted : July 12, 2017
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Slawa Cwajna, Nova Scotia Health Authority

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary Liver Cancer Metastatic Liver Cancer Drug: Primovist Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Cone-beam Computed Tomography for Image Guided Stereotactic Body Radiation Therapy of the Liver Using Gadoxetate Disodium
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Participants receiving Primovist
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.
Drug: Primovist

Primovist is currently a drug marketed for MRI. In this study it will be administered intravenously at 4 times what it is quoted for MRI to enhance the different imaging modality (CBCT) to improve the accuracy of liver SBRT. Although liver SBRT usually consists of 5 treatments, contrast will only be administered during the first treatment.

Consulting Health Canada and Bayer HealthCare Canada (the drug manufacturer) deemed this use "off label dosing" which in Canada is at the discretion of the physician. Based on preliminary imaging testing, and a review of toxicity literature for this drug, the administration for this specific use was deemed appropriate to give adequate image quality, while simultaneously maintaining patient safety.

Other Names:
  • Gadoxetate disodium
  • Gd-EoB-DTPA




Primary Outcome Measures :
  1. Improved image quality after injection as determined by contrast-to-background calculation and expert observation. [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Toxicity with "off label" dosing [ Time Frame: 12 months ]
    Categorized as adverse reaction or no adverse reaction post monitoring.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215355


Locations
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Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Sponsors and Collaborators
Slawa Cwajna
Nova Scotia Health Authority
Investigators
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Principal Investigator: Slawa Cwajna, MD Nova Scotia Health Authority
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Responsible Party: Slawa Cwajna, Radiation Oncologist (MD), Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03215355    
Other Study ID Numbers: NSHAREB#4793
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Slawa Cwajna, Nova Scotia Health Authority:
Adaptive radiotherapy
Contrast media
Cone-beam computed tomography
Stereotactic body radiation therapy
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases