Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
NCT ID: NCT03896646
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
42 participants
INTERVENTIONAL
2019-10-10
2026-09-30
Brief Summary
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Detailed Description
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I. To achieve tumor objective response rates of 75% using voxel based dosimetry when the mean dose (Dmean) to tumor is targeted to be greater than 200 Gray (Gy).
SECONDARY OBJECTIVES:
I. Correlate changes in liver function and Common Terminology Criteria for Adverse Events (CTCAE) incidence to the mean absorbed dose to normal liver.
II. Prospectively validate the accuracy of our published tumor dose response prediction based on the yttrium Y 90 glass microspheres (yttrium-90 \[Y90\]) tumor dose volume histograms (DVHs).
III. Correlate predicted tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan).
IV. Develop a tumor dose response model prediction based on the MAA dose maps. V. Develop a model correlating normal liver radiation dose to liver function using single-photon emission computed tomography/computed tomography hepatobiliary iminodiacetic acid (SPECT/CT HIDA) imaging.
VI. Develop a model correlating the relative tumor to normal liver enhancement on CT imaging and Cone beam CT imaging to the uptake on SPECT CT Tc99m MAA imaging (gold standard).
VII. Compare tumor and normal liver doses estimations from SPECT CT Bremsstrahlung imaging to positron emission tomography (PET) CT imaging.
OUTLINE:
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
After completion of study treatment, patients are followed up at 3 and 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (personalized radioembolization, SPECT/CT HIDA)
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
Computed Tomography
Undergo SPECT/CT HIDA scan
Hepatobiliary Iminodiacetic Acid Scan
Undergo SPECT/CT HIDA scan
Single Photon Emission Computed Tomography
Undergo SPECT/CT HIDA scan
Yttrium Y 90 Glass Microspheres
Undergo radioembolization with yttrium Y 90 glass microspheres
Yttrium-90 Microsphere Radioembolization
Undergo yttrium-90 microsphere radioembolization
Interventions
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Computed Tomography
Undergo SPECT/CT HIDA scan
Hepatobiliary Iminodiacetic Acid Scan
Undergo SPECT/CT HIDA scan
Single Photon Emission Computed Tomography
Undergo SPECT/CT HIDA scan
Yttrium Y 90 Glass Microspheres
Undergo radioembolization with yttrium Y 90 glass microspheres
Yttrium-90 Microsphere Radioembolization
Undergo yttrium-90 microsphere radioembolization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one lesion \>/= 3.0 cm in shortest dimension
3. AST or ALT \<5 times ULN
4. Bilirubin \</= 2.0 mg/dL (unless segmental infusion is used)
5. Negative pregnancy test in premenopausal women
Exclusion Criteria
2. Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) to the lungs with a single injection, or greater than 50 Gy for multiple injections
3. Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
4. Significant extrahepatic disease representing an imminent life-threatening outcome
5. Severe liver dysfunction or pulmonary insufficiency
6. Active uncontrolled infection
7. Significant underlying medical or psychiatric illness
8. Pregnant
9. Pre-existing diarrhea/illness, co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk
10. Infiltrative tumors
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Armeen Mahvash
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-01586
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-1008
Identifier Type: OTHER
Identifier Source: secondary_id
2018-1008
Identifier Type: -
Identifier Source: org_study_id
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