N/A
N=4
TheraSphere® For Treatment of Metastases in Liver
Colorectal Cancer Metastatic · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04517643 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Number of Patients That Met the Criterion That the Dose Estimated With Tc-99m MAA SPECT Was Within 15% of the Dose Estimated From Y-90 SPECT — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therasphere Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Met the Criterion That the Dose Estimated With Tc-99m MAA SPECT Was Within 15% of the Dose Estimated From Y-90 SPECT |
4 | — |
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 tomography (PET)/CT.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04517643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.