Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
NCT ID: NCT03997370
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
350 participants
INTERVENTIONAL
2020-01-15
2028-02-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (iohexol, standard care carboplatin, blood samples)
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
Undergo collection of blood samples
Carboplatin
Given IV
Iohexol
Given IV
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Carboplatin
Given IV
Iohexol
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For men who are sexually active, the need for use of medically acceptable contraception will be dictated by the primary treatment plan/protocol
* Study accrual was closed to women on 08/18/2021 and accrual is now only open to males in order to meet accrual goals and study objectives. (11-AUG-2021)
* Male sex
* Any patients who will receive treatment with intravenous carboplatin (any AUC, any cycle) on a National Cancer Institute (NCI)-sponsored National Clinical Trial Network (NCTN)-, Experimental Therapeutics Clinical Trials Network (ETCTN)-, trial, local trial, or through standard of care
* Age \>= 18
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria
* History of allergic reactions to computed tomography (CT) contrast, iodine or shellfish, or history of anaphylactic reaction to any food item
* Recent (last 6 months) episode of acute kidney injury, have sickle cell disease, or have current indwelling nephrostomy tubes
* Edema beyond trace edema, because this will impact iohexol equilibration and distribution
* Ascites (including pleural effusion) beyond trace ascites, because this will impact iohexol equilibration and distribution
* Whole- or part-limb amputees, because this will impact iohexol equilibration and distribution
* Inability to maintain a constant dose and schedule of anti-inflammatory agents, diuretics, angiotensin II receptor blockers (ARB) and angiotensin converting enzyme inhibitors (ACEi) for one week prior to study visit, as this impacts renal function. If the patient is on a nonsteroidal anti-inflammatory drug (NSAID), diuretic, ARB or ACEi, they are eligible as long as these agents are taken on a set schedule for 7 or more days prior to study (and not on an "as needed" basis as that can cause fluctuations in renal function)
* Inadequate venous access to obtain pharmacokinetic (PK) specimens
* Multinodular goiter, Graves' disease or autoimmune thyroiditis, per iohexol package insert (hypothyroidism is allowed)
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Responsible Party
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Principal Investigators
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Sarah E Taylor
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UC San Diego Health System - Encinitas
Encinitas, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Saint Mary's Hospital
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Carle BroMenn Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Reid Health
Richmond, Indiana, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States
Saint Anthony Regional Hospital
Carroll, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Lake Regional Hospital
Osage Beach, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Hi-Line Sletten Cancer Center
Havre, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Clara Maass Medical Center
Belleville, New Jersey, United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, United States
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Elizabeth, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
The Cancer Institute at Saint Francis Hospital
East Hills, New York, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Highland Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Good Samaritan University Hospital
West Islip, New York, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Orion Cancer Care
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
First Dayton Cancer Care
Kettering, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Springfield Regional Cancer Center
Springfield, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Dayton Physicians LLC - Troy
Troy, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Saint Joseph Warren Hospital
Warren, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, United States
Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee, United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Monongalia Hospital
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Memorial Hospital of Laramie County
Cheyenne, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Cancer Center-Metro Medical Center Bayamon
Bayamón, , Puerto Rico
Puerto Rico Hematology Oncology Group
Bayamón, , Puerto Rico
HIMA San Pablo Oncologic Hospital
Caguas, , Puerto Rico
Doctors Cancer Center
ManatÃ, , Puerto Rico
Instituto Oncologia Moderna Ponce
Ponce, , Puerto Rico
San Juan Community Oncology Group
San Juan, , Puerto Rico
Primary Care Physician Group
San Juan, , Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
PROncology
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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Facility Contacts
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Other Identifiers
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NCI-2019-04008
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-GY022
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GY022
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GY022
Identifier Type: -
Identifier Source: org_study_id
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