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Alkylating agents

Iohexol-aided Carboplatin Dosing for Cancer

Phase 1
Recruiting
Led By Sarah E Taylor
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18
Male sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial is testing whether iohexol can help doctors calculate the dose of carboplatin given to cancer patients.

Who is the study for?
This trial is for male cancer patients aged 18 or older who will receive carboplatin chemotherapy. They must be in good general health, able to follow the study plan, and provide informed consent. Men should use contraception as dictated by their treatment protocol. Women are not eligible due to study objectives.Check my eligibility
What is being tested?
The trial is testing how well iohexol helps calculate the correct dose of carboplatin for cancer treatment. It aims to improve dosing accuracy of carboplatin by studying its interaction with iohexol and collecting biospecimens from participants.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to iohexol (similar to those seen with CT contrast agents), issues affecting kidney function, and possible interference with thyroid gland activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am male.
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I am a male interested in joining the study.
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I will be treated with carboplatin through a clinical trial or as standard care.
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I am mentally and physically able to follow the study's requirements.
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I will use contraception as required by my treatment plan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of achieving the targeted carboplatin area under the curve (AUC)
Bias of the formula for estimated glomerular filtration rate (eGFR) currently in existence in patients with cancer
Correlation between carboplatin clearance (CL) and mGFR
+2 more
Secondary outcome measures
Ability of markers in addition to creatinine in pre-treatment serum to better estimate kidney function in patients with cancer
Divergence of eGFR from mGFR
Relationship between carboplatin exposure and toxicity
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (iohexol, standard care carboplatin, blood samples)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iohexol
2016
Completed Phase 4
~1920
Carboplatin
2014
Completed Phase 3
~6670
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,502 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,997 Total Patients Enrolled
Sarah E TaylorPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
22 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03997370 — Phase 1
Cancer Research Study Groups: Treatment (iohexol, standard care carboplatin, blood samples)
Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03997370 — Phase 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997370 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in the current clinical trial?

"This clinical trial necessitates 250 eligible participants, and recruiting is taking place in two centres - UPCI located in Pittsburgh, Pennsylvania; and Saint Louis Cancer & Breast Institute-Ballwin in Ballwin, New york."

Answered by AI

Are there any precedents of research that have utilized Iohexol?

"Iohexol was initially investigated in 2002 at H Central de Asturias. Since then, 866 studies have been completed with 711 currently active experiments, many of which are conducted out of Pittsburgh, Pennsylvania."

Answered by AI

What medical issues can Iohexol aid in alleviating?

"Iohexol is frequently administered to treat non-Hodgkin lymphoma, but it may also be utilized in the management of sarcoma and Hodgkin disease."

Answered by AI

What potential hazards do patients face when taking Iohexol?

"Iohexol has been minimally studied, hence it received a score of 1 on our risk assessment scale. This is because this medical trial is in the early stages and lacks sufficient data to ensure safety."

Answered by AI

Are there a plentiful number of medical centers conducting this trial in North America?

"This study is being conducted in various locations, including University of Pittsburgh Cancer Institute (UPCI) in Pennsylvania, Saint Louis Cancer and Breast Institute-Ballwin in New york, Memorial Sloan Kettering Cancer Center in Virginia, and a further 100 sites."

Answered by AI

Are new participants being enrolled in this research project?

"Clinicaltrials.gov reports that recruitment for this clinical trial is still ongoing, following its initial posting on November 18th 2019 and latest update from August 31st 2022."

Answered by AI

What are the main goals of this medical experiment?

"The principal objective of this 4-week clinical trial is to discover the relationship between carboplatin clearance and mGFR. Secondary goals involve measuring the divergence of eGFR from mGFR, ascertaining how accurately target carboplatin AUCs can be reached among patients with elevated eGFR levels, and assessing if pre-treatment serum markers other than creatinine aid in providing an estimate for kidney function for cancer patients."

Answered by AI
~142 spots leftby Feb 2027