- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028311
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer
Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography.
SECONDARY OBJECTIVES:
I. To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology.
II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity.
III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user.
OUTLINE:
The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.
All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.
After completion of study treatment, patients are followed up at 1, 3, and 6 months.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
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:
- The ability to understand and sign informed consent
- Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors
Exclusion Criteria:
- Patients with greater than 50% liver tumor burden
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 |
---|---|
Other: Treatment (angiography, yttrium Y-90 radioembolization)
The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours. |
Undergo angiography
Undergo planar imaging
Undergo SPECT-CT
Other Names:
Undergo radioembolization
Other Names:
Undergo SPECT-CT
Other Names:
Given via arterial catheter
Other Names:
Given via arterial catheter
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of same day yttrium Y-90 radioembolization planning and treatment angiography
Time Frame: Up to 6 months
|
Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation.
Feasibility will be defined as at least 9 successful same day treatments.
A procedure lasting greater than 4 hours will be considered a failure.
The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined.
Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule.
Success status will be summarized using frequencies and percentages.
Success rate will be estimated along with exact 95% confidence interval.
Patient characteristics will be summarized using appropriate summary statistics.
|
Up to 6 months
|
Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame: Up to 6 months
|
The summaries will be overall (severity grades 1 through 5).
Actions taken for grade 3 events will also be reported.
The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported.
Laboratory values will be summarized by the treatment group over time.
|
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
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
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Technetium Tc 99m Aggregated Albumin
Other Study ID Numbers
- 2016-0244 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2017-00629 (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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