Status:
COMPLETED
TheraSphere® For Treatment of Metastases in Liver
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Colorectal Cancer Metastatic
Colorectal Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
To investigate whether the dose predicted by pre-therapy 99mTc MAA SPECT predicts the dose to the liver from the 90Y microspheres as assessed by post-therapy 90Y SPECT/CT or positron emission tomograp...
Detailed Description
This study will acquire imaging information from 3-5 patients that will demonstrate feasibility of future implementation of personal dosimetry-based treatment planning for Trans-arterial Radio-emboliz...
Eligibility Criteria
Inclusion
- The Diagnosis of metastatic colorectal cancer to the liver
- Patients with a diagnosis of metastatic colorectal cancer to the liver
- Liver metastases are unresectable
- Tumors are hypervascular based on visual estimation by the Investigator
- Target tumors are measurable using standard imaging techniques
- Performance Status Score 0 - 2
- Age ≥18 years
- Life expectancy ≥3 months
- \>4 weeks since prior radiation, surgery or chemotherapy
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- At least one month has elapsed since most recent prior cancer therapy with the following exception:
- Patient is willing to participate in the study and has signed the study informed consent
Exclusion
- Patients may not be treated with TheraSphere® if patients have any of the following exclusions:
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction:
- Blood test result levels outside of the normal range
- Any history of hepatic encephalopathy
- Any contraindications to angiography and hepatic artery catheterization such as:
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives or atropine that cannot be corrected or premedicated
- Bleeding diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization.
- Evidence of pulmonary insufficiency
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment or, in the judgment of the physician, place the patient at undue risk
- Pregnancy
- Special Categories of Patients: Not applicable
- Research in Mentally Disabled People: No. All participants or legal guardians will be fully able to give informed consent.
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04517643
Start Date
November 12 2020
End Date
December 1 2022
Last Update
October 6 2023
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231