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

Running, not enrolling · Phase 1

Conditions studied: Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT03997370

Run by

NRG Oncology

People needed

350

Starts

2020-01-15

Expected to finish

2028-03-14

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
• 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

You may not qualify if…

• Treated at an institute where creatinine is not measured with an IDMS calibrated assay
• 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)

Where it is running

• 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
• University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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