Clinical trial NCT03028311: Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer
Official title: Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic Liver Carcinoma
Stage IV Liver Cancer
Stage IVA Liver Cancer
Stage IVB Liver Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success of same day yttrium Y-90 radioembolization planning and treatment angiography
timeFrame: Up to 6 months
measure: Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Armeen Mahvash
role: PRINCIPAL_INVESTIGATOR
References: