Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

All Drugs and Chemicals

Liver Extracts

Technetium Tc 99m Aggregated Albumin

Radiopharmaceuticals

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.

Angiography

Computed Tomography

Planar Imaging

Radioembolization

Single Photon Emission Computed Tomography

Technetium Tc-99m Albumin Aggregated

Yttrium Y 90 Resin Microspheres

Armeen Mahvash

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.

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.

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer

Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment

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.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Esophageal Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Carcinoma, Squamous Cell

Gastrointestinal Stromal Tumors

Esophageal Squamous Cell Carcinoma

Intestinal Neoplasms

Thoracic Neoplasms

Rectal Neoplasms

Colonic Neoplasms

Neoplasms, Squamous Cell

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Colorectal Neoplasms

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Head and Neck Neoplasms

Esophageal Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Acute Graft Versus Host Disease

Small Intestine Cancer

Patients receive standard of care consisting of oncology care provided via telemedicine.

Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Patient receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring and biometric monitoring.

Best Practice

Patient Monitoring

Questionnaire Administration

Ryan W Huey, MD

Ryan W Huey

This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.

PRIMARY OBJECTIVE:

I. Determine the efficacy of remote patient monitoring (RPM) on improving clinical outcomes.

SECONDARY OBJECTIVE:

I. Evaluate the following patient-centered outcomes: treatment delays, health-related quality-of-life (HRQOL), patient activation, and family caregiver-experience.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care consisting of oncology care provided via telemedicine.

ARM II: Patients receive standard of care consisting of oncology care provided via telemedicine. Patients also undergo remote monitoring.

Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

There Is No Place Like Home- A Pragmatic Effectiveness Trial of Technology-Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events

Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period.

HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1.

Patient engagement will be evaluated with the 13-item Patient Activation Measure (PAM), which assesses knowledge, skill, and self-efficacy for self-management of health

Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer	NCT03028311	Metastatic Live... Stage IV Liver ... Stage IVA Liver... Stage IVB Liver...	Angiography Computed Tomogr... Planar Imaging Radioembolizati... Single Photon E... Technetium Tc-9... Yttrium Y 90 Re...	18 Years -	M.D. Anderson Cancer Center
Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events	NCT05038254	Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Metastatic Colo... Metastatic Esop... Metastatic Gast... Metastatic Live... Metastatic Mali... Metastatic Mali... Metastatic Mali... Metastatic Panc... Metastatic Rect... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Stage IV Colon ... Stage IV Hepato... Stage IV Pancre... Stage IV Rectal... Stage IV Small ... Stage IVA Colon... Stage IVA Hepat... Stage IVA Recta... Stage IVB Colon... Stage IVB Hepat... Stage IVB Recta... Stage IVC Colon... Stage IVC Recta...	Best Practice Patient Monitor... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer	NCT03028311	Metastatic Live... Stage IV Liver ... Stage IVA Liver... Stage IVB Liver...	Angiography Computed Tomogr... Planar Imaging Radioembolizati... Single Photon E... Technetium Tc-9... Yttrium Y 90 Re...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for metastatic liver carcinoma