Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Stereotactic body radiotherapy

Iodixanol

Iohexol

Aya Kamaya

The purpose of this study is first, to determine whether baseline perfusion characteristics of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to determine whether baseline perfusion characteristics in those patients with resectable pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel density and vascular endothelial growth factor (VEGF) expression.

Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

Prognostic Value of Baseline CT Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

Stanford University

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Small Cell Lung Cancer

Malignant Mesothelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

stereotactic body radiation therapy \& pulmonary interstitial lymphography

Standard of care diagnostic radiotherapy procedure

Stereotactic Body Radiation Therapy (SBRT)

For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the water-soluble contrast

Computed Tomography (CT)

Linear accelerator for producing high energy x-rays for radiation therapy.

Cyberknife

Trilogy

True Beam

Aqueous solution of a nonionic, water-soluble radiographic contrast medium in prefilled cartridges with a molecular weight of 821.14 (iodine content 46.36%), available at 140, 180, 240, 300, and 350 mgI/mL.

Aqueous solution of a nonionic, water-soluble, dimeric, isosmolar, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%), available in 2 concentrations, (270 mgI/mL and 320 mgI/mL.

Billy W Loo, Jr, MD, PhD

Jonathan Abelson, MD

The stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy with lymphadenectomy. This procedure (lobectomy) does not fulfill the medical need as many patients are poor operative candidates or decline surgery.

This study assesses the feasibility of stereotactic body radiation therapy (SBRT) as a tool to produce therapeutically useful computed tomography (CT) scans, using standard water-soluble iodinated compounds as the contrast agents.

Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from phase 1-2 studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.

Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.

We propose to conduct a study to determine the feasibility of visualizing, by computed tomography (CT) scans, water-soluble iodinated contrast materials after direct injection into the tumor. Integration into radiation therapy treatment planning may also be assessed.

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Associate Professor of Radiation Oncology

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

Laxatives

Cathartics

Patients will be recruited from a pool scheduled to undergo screening or diagnostic CTC for clinical purposes. They will be given 50 ml of Iohexol as a oral contrast

Iohexol (Omnipaque; GE Healthcare, Milwaukee, WI) is a low-osmolar non-ionic iodinated contrast agent that is approved by the FDA for oral use. It is routinely used orally for CT scans of the abdomen and pelvis, and has been used experimentally in CTC. Iohexol is better tolerated by patients and has a better safety profile than hyperosmolar iodinated and barium based contrast agents.

Parina Shah, MS, MHA

Judy Yee, MD, FACR

CT colonography (CTC) is a validated screening exam for colorectal cancer. The diagnostic accuracy of CTC depends on the quality of the bowel cleansing and contrast tagging of residual stool and fluid. New bowel preparation media for CTC should be assessed for their efficacy and for patient satisfaction. Iohexol is currently approved by the FDA for oral use for imaging of the gastrointestinal tract. A potential advantage of using iohexol for CTC is that low-and iso-osmolar oral contrast agents have fewer risks than hyperosmolar contrast agents, which make them ideal for use in all patients, especially those who are frail and/or have multiple co-morbidities. For example, hyperosmolar contrast agents that are accidentally aspirated into the lungs during ingestion may result in life-threatening acute pulmonary edema and severe chemical pneumonitis, which is not the case for low- and iso-osmolar contrast agents. It may even be safer to use low- or iso-osmolar contrast agents for patients undergoing CTC on the same day as their incomplete colonoscopy, since they are at risk for aspiration from being sedated for their colonoscopy. Additionally, unlike hyperosmolar contrast agents, low- and iso-osmolar contrast agents do not cause sudden and massive fluid shifts, thus eliminating the risk of dangerous electrolyte imbalances.

Colorectal cancer is the third most common cancer and the second leading cause of cancer-related mortality in the United States when both sexes are combined. Given that the time interval between the appearance of a pre-malignant adenoma and its progression to invasive carcinoma is approximately 5.5 years for polyps \>10 mm and 10-15 years for smaller polyps, colorectal cancer is an ideal disease for screening because there is sufficient time to detect and remove pre-malignant adenomas. However, even though screening has been shown to decrease colorectal cancer mortality, only about 60% of people over the age of 50 have had the recommended screening tests.

First introduced in 1994, computed tomography colonography (CTC) is a validated colorectal cancer screening exam by the American Cancer Society. It is a low-radiation dose CT scan of the colon that is performed after bowel preparation and gas insufflation of the colon. CTC has several advantages over optical colonoscopy including less invasiveness, no need for sedation, improved patient comfort, and the ability to identify extracolonic findings. The performance of CTC for polyp detection compares favorably to that of optical colonoscopy and CTC is rapidly gaining acceptance as a screening and diagnostic technique.

For accurate diagnosis in CTC, the colon must be adequately cleansed and any residual stool and fluid must be tagged so that they do not obscure polyps or masses. Patients often find bowel preparation to be the most onerous part of the screening process because it is inconvenient and uncomfortable. Many bowel preparations for CTC and optical colonoscopy require ingestion of large volumes of laxative solutions that can lead to nausea, abdominal pain and diarrhea. Additionally, for CTC, currently the most widely used tagging agents are hyperosmolar iodinated and barium based agents such as diatrizoate meglumine and diatrizoate sodium solution (Gastrografin; Bracco Diagnostics, Monroe Township, NJ), a hyperosmolar ionic iodinated contrast agent. These hyperosmolar agents can also lead to nausea, abdominal pain and diarrhea, and can even result in dangerous electrolyte balances from rapid fluid shifts. Changing the current bowel preparation regimen to improve patient comfort, convenience, and safety would most likely increase patient compliance with CTC.

Iohexol (Omnipaque; GE Healthcare, Milwaukee, WI) is a low-osmolar non-ionic iodinated contrast agent that is approved by the FDA for oral use. It is routinely used orally for CT scans of the abdomen and pelvis, and has been used experimentally in CTC. Iohexol is better tolerated by patients and has a better safety profile than hyperosmolar iodinated and barium based contrast agents.

Study Hypotheses

1. Oral iohexol in conjunction with a minimally cathartic agent results in adequate bowel preparation for CTC.
2. Oral iohexol provides effective tagging of residual stool and fluid in standard screening and diagnostic CTC and same-day CTC following incomplete optical colonoscopy.
3. Oral iohexol is well tolerated by patients in terms of taste, ease of preparation, and side effects.

Virtual Colonoscopy Using Omnipaque as a Contrast Agent

Low-osmolar Contrast Tagging in Minimal Cathartic CT Colonography

Two experienced board-certified abdominal imaging radiologists trained in reading CTC will assess percent bowel preparation

Two experienced board-certified abdominal imaging radiologists trained in reading CTC will assess residual fluid in each of the six segments of the colon (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum)- Each segment will be scored as - 1 - none, 2 - \<25%, 3 - 25-50%, 4: 50-75%, 5: \>75%

Two experienced board-certified abdominal imaging radiologists trained in reading CTC will assess residual fluid in each of the six segments of the colon (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum) It will be recorded in Hounsfield units from ROI of fluid in each segment

Patient satisfaction with Omnipaque 350 as part of their bowel preparation regimen will be assessed with Likert scales in a questionnaire that patient will be asked to fill out after CTC.

A subset analysis on the workflow of incomplete colonoscopies will also be performed. Specifically those patients who have an incomplete colonoscopy and have a CTC the same day with the Omnipaque regimen and those patients who choose to reattempt or forgo Colorectal cancer screening until a later date.

The time and resources between those patients who have CTC on the same-day with the Omnipaque regimen after incomplete colonoscopy and the other subset will be compared and determination of the effectiveness of both workflows will be made. This will be used to gauge the productivity for the site.

GE Healthcare

Montefiore Medical Center

Antineoplastic Agents

Carboplatin

Patients receive iohexol IV over 30-60 seconds. Patients then receive standard of care carboplatin IV. Patients also undergo collection of 7-8 blood samples for analysis.

Biospecimen Collection

Site Public Contact

Setsuko K. Chambers

Jay W. Carlson

Heather R. Williams

Jyoti S. Mayadev

Hui Chen

Bradley R. Corr

Sarah E. Gill

John M. Schallenkamp

Daniela E. Matei

Maria T. Grosse-Perdekamp

Mary T. Jenkins Vogel

Howard M. Gross

Joshua Lukenbill

Stephanie L. Gaillard

Christopher Tarney

Tashanna K. Myers

Nicola M. Spirtos

Roisin E. O'Cearbhaill

Eugenia Girda

Ana Maria Lopez

Ken Y. Lin

Emese Zsiros

Sarah E Taylor

This trial studies how well iohexol works in helping doctors calculate the dose of carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future.

PRIMARY OBJECTIVES:

I. Evaluate the success of targeting a carboplatin area under the curve (AUC) with our current approach to dosing carboplatin.

II. Assess the performance of Cockcroft-Gault (CG), four-variable Modification of Diet in Renal Disease (MDRD-4), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) based on isotope dilution mass spectrometry (IDMS) calibrated serum creatinine in predicting measured glomerular filtration rate (mGFR) in patients with cancer.

III. Define the relationship of mGFR and carboplatin clearance in patients with cancer.

SECONDARY OBJECTIVES:

I. Evaluate the divergence of estimated (e)GFR from mGFR based on patient demographic and other characteristics, thus identifying those most likely to benefit from determination of mGFR over use of eGFR.

II. Determine the success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped.

III. Evaluate the relationship between carboplatin exposure and toxicity. IV. Assess the ability of markers other than creatinine in pre-treatment serum to better estimate kidney function in patients with cancer.

OUTLINE:

Patients receive iohexol intravenously (IV) over 30-60 seconds. Patients then receive standard of care carboplatin IV. Patients also undergo collection of 7-8 blood samples for analysis.

After completion of study, patients are followed up for 3-4 weeks.

Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol

Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin

Will be quantified by the median percentage error (PE), root-mean-squared error (RMSE), interquartile range (IQR) of the residuals, and median absolute percentage error (APE). In addition, the percentage of patients for which the observed carboplatin AUC is within 17% of target will be calculated. The actual AUC will be quantified using atomic absorption spectrophotometry.

Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE. In addition, the percentage of patients for which the observed carboplatin AUC is within 17% of target will be calculated. The actual AUC will be quantified using atomic absorption spectrophotometry.

Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE will be used to assess the accuracy of each model's eGFR values for predicting measured (m)GFR. In addition, will calculate the percentage of patients for which eGFR is within 30%, 20%, and 10% of mGFR.

Will be quantified by the median PE, RMSE, IQR of the residuals, and median APE will be used to assess the accuracy of each model's eGFR values for predicting mGFR. In addition, will calculate the percentage of patients for which eGFR is within 30%, 20%, and 10% of mGFR.

Assessed by regression analysis. Carboplatin clearance will be derived by Empirical Bayes estimation using the POSTHOC option implemented in NONMEM. Will perform regression on the relationship between CL and mGFR. Initially this will follow a linear relationship analogous to the Calvert formula (CL = A + B\* mGFR), and will test if the observed values for A and B are significantly different from those defined by Calvert as A = 25 mL/min and B = 1 (unitless). Will also perform regression by other means, e.g. after log transformation of the data, and assess if this results in a formula that performs better than the Calvert formula or the initial linear model. In addition, the impact of covariates on this relationship will be explored.

The bias of eGFR versus mGFR will be modeled as a function of the patient's characteristics.

Among patients with eGFR \> 125 mL/min, precision and bias will be estimated relative to the target carboplatin AUC.

Will be described by the regression parameters for the estimated relationship between carboplatin AUC and platelet count, neutrophil count, and non-hematologic grade 3 toxicities.

These markers will include (but are not limited to) cystatin C, beta-2-microglobulin (B2M), and beta-trace-protein (BTP). Will use these markers and patient covariates (e.g. sex, race, weight etc.) as predictors for mGFR in regression efforts.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection	NCT01326364	Pancreatic Canc...	Stereotactic bo... Iodixanol Iohexol	18 Years -	Stanford University
Pulmonary Interstitial Lymphography in Early Stage Lung Cancer	NCT01188486	Lung Cancer Lung Cancer Non... Lung Cancer Sma... Mesothelioma	Stereotactic Bo... Computed Tomogr... Cyberknife Trilogy True Beam Iohexol Iodixanol	18 Years -	Stanford University
Virtual Colonoscopy Using Omnipaque as a Contrast Agent	NCT04582500	Colorectal Canc...	Iohexol	18 Years -	Montefiore Medical Center
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol	NCT03997370	Malignant Solid...	Biospecimen Col... Carboplatin Iohexol	18 Years -	NRG Oncology
Pulmonary Interstitial Lymphography in Early Stage Lung Cancer	NCT01188486	Lung Cancer Lung Cancer Non... Lung Cancer Sma... Mesothelioma	Stereotactic Bo... Computed Tomogr... Cyberknife Trilogy True Beam Iohexol Iodixanol	18 Years -	Stanford University
Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection	NCT01326364	Pancreatic Canc...	Stereotactic bo... Iodixanol Iohexol	18 Years -	Stanford University

Spots Global Cancer Trial Database for iohexol

Every month we try and update this database with for iohexol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iohexol

Every month we try and update this database with for iohexol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iohexol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.