- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03896646
Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Armeen Mahvash
- Phone Number: 713-563-7340
- Email: armeen.mahvash@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients over 18 years of age, of any race or sex, who have unresectable hepatocellular carcinoma of the liver, and who are able or have a fully able legal guardian to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of </=2, with a life expectancy of >/=3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least one month post chemotherapy.
- At least one lesion >/= 3.0 cm in shortest dimension
- AST or ALT <5 times ULN
- Bilirubin </= 2.0 mg/dL (unless segmental infusion is used)
- Negative pregnancy test in premenopausal women
Exclusion Criteria:
- Contraindications to angiography and selective visceral catheterization
- 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
- 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)
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Pregnant
- Pre-existing diarrhea/illness, co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk
- Infiltrative tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Undergo SPECT/CT HIDA scan
Other Names:
Undergo SPECT/CT HIDA scan
Other Names:
Undergo SPECT/CT HIDA scan
Other Names:
Undergo radioembolization with yttrium Y 90 glass microspheres
Other Names:
Undergo yttrium-90 microsphere radioembolization
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor objective response rate (ORR)
Time Frame: Up to 6 months
|
Assessed with modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
The ORR of treated tumors will be determined.
Will perform a cluster bootstrap in which patients (not tumors) are sampled with replacement.
Will construct a 95% confidence interval using the 2.5% and 97.5% quantiles of the bootstrap sampling distribution.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in liver function
Time Frame: Up to 6 months
|
Will analyze the correlation in changes in liver function to the mean absorbed dose to normal liver.
The hepatobiliary iminodiacetic acid (HIDA) scan will be used to estimate the body-surface area corrected mebrofenin clearance rate in %-activity/sec/m^2 using published methodology.
The change in liver function after radioembolization will be calculated and correlated to the radiation dose distribution to the normal liver.
Will use Wilcoxon and two-sample t-tests to measure significance of association.
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Up to 6 months
|
Changes in Common Terminology Criteria for Adverse Events (CTCAE) incidence
Time Frame: Up to 6 months
|
Will analyze the correlation in changes in CTCAE incidence to the mean absorbed dose to normal liver.
Will create waterfall charts of CTCAE and mean absorbed normal liver in liver.
Will use Wilcoxon and two-sample t-tests to measure significance of association and scatterplots and regression (linear or non-linear) to predict actual doses delivered from predicted tumor dose.
|
Up to 6 months
|
Accuracy of published tumor dose response prediction based on the yttrium-90 (Y90) tumor dose volume histograms
Time Frame: Up to 6 months
|
Lin's concordance correlation, t-test, and Bland-Altman analysis will be performed on pair-wise estimate of tumor doses.
Develop tumor dose response curves using logistic regression and assess significance of parameters.
Furthermore, we will compute the half-maximal dose (D50%), positive predictive value, negative predictive value and its 95% confidence interval from this prospective study.
These values will be compared to those from the retrospective study for equivalence using the z-test.
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Up to 6 months
|
Prediction of tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan)
Time Frame: Up to 6 months
|
Lin's concordance correlation, t-test, and Bland-Altman analysis will be performed on pair-wise estimate of tumor doses.
Will use scatterplots and regression (linear or non-linear) to predict actual doses delivered from predicted tumor dose.
A correlation analysis of the predicted tumor doses from the MAA images with the actual tumor doses delivered from Y90 images will be performed.
The linear-correlation coefficient will be computed.
A Bland-Altman analysis will be performed to compute the bias and the 95% limits of agreement.
|
Up to 6 months
|
Development of tumor dose response model prediction based on MAA dose maps
Time Frame: Up to 6 months
|
Mean tumor doses based the planning 99mTc-MAA images will be computed using voxel dosimetry.
A univariate logistic regression model will used to determine tumor dose metrics (D50%) that correlated with mRECIST-based tumor response at 3 and 6 months.
|
Up to 6 months
|
Development of 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
Time Frame: Up to 6 months
|
A regression analysis of the change in liver function from the pre- and post-procedural HIDA SPECT/CT scans (changes in %/min) as a function of the normal liver absorbed dose will be performed.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Armeen Mahvash, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- Iminodiacetic acid
Other Study ID Numbers
- 2018-1008 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2019-01586 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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