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Evaluating how iohexol helps calculate carboplatin doses for cancer treatment

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

Phase 1 Interventional NRG Oncology · NCT03997370

This study tests if using iohexol can help doctors figure out the right dose of carboplatin for cancer patients with solid tumors.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years and up
SexMale
SponsorNRG Oncology Academic / other
Drugs / interventionschemotherapy
Locations179 sites (Tucson, Arizona and 178 other locations)
Trial IDNCT03997370 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of iohexol in assisting healthcare providers to accurately determine the dosage of carboplatin for patients with malignant solid tumors. The study aims to evaluate various methods for estimating kidney function and their correlation with carboplatin clearance. Participants will receive iohexol intravenously followed by carboplatin, with blood samples collected for analysis. The trial also seeks to identify patient characteristics that may influence the accuracy of kidney function estimates and the relationship between carboplatin exposure and toxicity.

Who should consider this trial

Good fit: Ideal candidates for this study are male patients aged 18 and older who are scheduled to receive intravenous carboplatin as part of their cancer treatment.

Not a fit: Patients who are female or those treated at institutions without IDMS calibrated creatinine measurement will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more precise dosing of carboplatin, potentially improving treatment outcomes for cancer patients.

How similar studies have performed: Other studies have explored similar dosing methodologies, but this specific approach using iohexol for carboplatin dosing is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Tucson, Arizona and 178 other locations

+129 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Malignant Solid Neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.