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

Thyroid Diseases

Thyroid Nodule

Adenocarcinoma, Follicular

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

Anti-Infective Agents, Local

Trace Elements

Patients receive iodine-123 PO and then undergo planar imaging and a SPECT/CT scan on study.

Iodine I-123

Clinical Trials Referral Office

Jolanta M. Durski, M.D.

This phase II study evaluates radioiodine planar and SPECT/CT imaging with iodine-123 in patients with follicular thyroid nodules prior to surgery. Because biopsy alone is not sufficient to distinguish between malignant follicular thyroid nodules and benign follicular thyroid nodules, patients with follicular thyroid lesions are referred for surgery for further evaluation. A non-invasive imaging method that can accurately determine malignancy in follicular thyroid nodules would be valuable in patient management and could potentially spare patients unnecessary surgery. Planar imagine uses a gamma camera to obtain 2D images and SPECT/CT imaging is a special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the tumor cells. Radioiodine planar and SPECT/CT imaging may be more accurate in distinguishing between benign follicular thyroid nodules and malignant follicular thyroid nodules to help reduce the need for surgery.

PRIMARY OBJECTIVES:

I. Determine the proportion of benign nodules appearing as hot/warm on radioiodine scans (nodule uptake \>= uptake in normal thyroid tissues).

II. To identify a possible relationship between iodine-123 (I-123) uptake on planar and single-photon emission computerized tomography (SPECT)/computerized tomography (CT) images and malignancy on surgical pathology in thyroid nodules which were previously identified by fine-needle aspiration (FNA) as indeterminate follicular neoplasms.

III. Examine correlations between intensity of uptake in follicular nodules before surgery (standard uptake values \[SUV\] on the quantitative reconstructions from our Veriton SPECT/CT scanner and nodule-to-normal thyroid background ratios on planar and SPECT images) and pathology findings and determine an SUV threshold that best distinguishes between benign and malignant nodules.

IV. Compare the usefulness of conventional planar imaging versus SPECT/CT imaging for thyroid nodules, in order to inform our optimal clinical protocol.

V. Establish an imaging protocol best suited for measuring uptake in small thyroid nodules.

OUTLINE:

Patients receive iodine-123 orally (PO) and then undergo planar imaging and a SPECT/CT scan on study.

Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery

Radioiodine Scanning for Pre-Surgical Evaluation of Follicular Thyroid Nodules

Adverse events will be assessed while patients are in the nuclear medicine division undergoing positron emission tomography/computed tomography imaging.

We will compare the intensity of uptake in malignant versus benign lesions.

Mayo Clinic

Mouth and Tooth Diseases

Rare Diseases

Carcinoma, Squamous Cell

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Lip Neoplasms

Neoplasms, Squamous Cell

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.

Computed Tomography (CT)

Imaging Agent

Undergo standard elective neck dissection

Neck Dissection

Sentinel Lymph Node Biopsy

Site Public Contact

Steven J. Wang

Emre A. Vural

Ellie G. Maghami

Theresa Guo

Fred Baik

Saral Mehra

Francisco J. Civantos

Jennifer Gross

Sandeep Samant

Mihir K. Bhayani

Nitin A. Pagedar

Andres M. Bur

John Pang

Steven B. Chinn

John D. Cramer

Eleanor M. Walker

Aru Panwar

Jennifer R. Cracchiolo

Dylan F. Roden

Ryan P. McSpadden

Umamaheswar Duvvuri

Jamie A. Ku

Amit Agrawal

Rusha J. Patel

Nitya Alluri

Nicholas Purdy

David M. Cognetti

Mark Kubik

Daniel Almquist

William C. Spanos

John P. Gleysteen

Michael C. Topf

Ann M. Gillenwater

Vlad C. Sandulache

Mirabelle Sajisevi

John R. de Almeida

Stephen Y Lai

This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

PRIMARY OBJECTIVES:

I. To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)

SECONDARY OBJECTIVES:

I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.

II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms.

IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:

IVa. Neck Dissection Impairment Index (NDII). IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH). IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.

VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.

VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.

EXPLORATORY OBJECTIVES:

I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire \[EQ-5D-5L\]) between surgical arms.

II. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy.

GROUP II: Patients undergo standard END.

After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.

Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point (change from Baseline to 6 months) between arm difference is clinically meaningful. The hypothesis of no between-arm difference in 6-month NDII scores will be tested using the ANCOVA model at one-sided significance level of 0.10. Point estimates and 95% confidence intervals (CIs) for the mean NDII scores at 6 months for each treatment arm and for the between-arm difference at 6-months based on the proposed model will be provided.

An event for disease-free survival is local recurrence, regional recurrence, distant metastasis, or death due to any cause. Disease-free survival time is randomization date to the date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

An event for overall survival is death due to any cause. Overall survival time is randomization date to date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

An event for local-regional failure is local or regional recurrence. Local-regional failure time is randomization date to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between arm differences compared using cause-specific log-rank test.

An event is the occurrence of distant metastasis. Distant metastasis time is randomization to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between-arm differences compared using cause-specific log-rank test.

Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.

Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N) to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index (FACT-TOI) scores on a scale from 0-96. A higher score indicates better quality of life.

Defined as the proportion of patients with pathologic positive nodes using the pathology results.

Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.

Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.

NRG Oncology

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
Radioiodine Planar and a SPECT/CT Imaging With Iodine-123 for Evaluation of Follicular Thyroid Nodules Prior to Surgery	NCT05591092	Thyroid Gland F...	Computed Tomogr... Iodine I-123 Planar Imaging Single Photon E...	18 Years -	Mayo Clinic
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer	NCT04333537	Buccal Mucosa S... Floor of Mouth ... Gingival Squamo... Hard Palate Squ... Lip Squamous Ce... Lower Alveolar ... Oral Cavity Squ... Retromolar Trig... Stage I Lip and... Stage II Lip an... Tongue Squamous... Upper Alveolar ...	Computed Tomogr... Imaging Agent Neck Dissection Planar Imaging Sentinel Lymph ... Single Photon E...	18 Years -	NRG Oncology
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

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