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Iodixanol

Clinical trials investigating Iodixanol are studying how it is used in different imaging and procedure settings. These studies look at outcomes such as detection accuracy, pregnancy results, pain relief, and kidney safety in people with breast disease, infertility, knee osteoarthritis, peripheral artery disease, cancer, and abdominal aortic aneurysm.

Table of contents

Clinical trials overview

The clinical trials investigating Iodixanol are not focused on one disease only. They study how it is used in imaging and procedure settings across several patient groups, including breast pathology, infertility, knee osteoarthritis, peripheral arterial disease, cancer, and abdominal aortic aneurysm.[1][2][3][4][5][6][7]

Most of the studies are Phase 2 or Phase 3 trials, which means they are mainly checking how well a strategy works in real patients and how it compares with another approach.[1][2][3][4][5][6] One study is listed as Low Intervention, meaning it uses a lower-risk research design with a strategy close to usual care.[7]

Breast imaging study

One authorised Phase 2 trial studies breast pathology and compares contrast-enhanced digital mammography alone and with tomosynthesis against magnetic resonance imaging (MRI).[1] Tomosynthesis is a type of layered breast X-ray imaging, and the study checks whether adding it helps find and classify breast lesions more accurately.[1]

The main outcome is equivalence/comparability, which means the researchers want to know whether the breast imaging methods give similar results for detection rate and diagnostic accuracy.[1] The study also looks at the extent of breast disease, including multifocality (more than one focus in the same area), multicentricity (lesions in different areas of the breast), and bilaterality (in both breasts).[1]

Fertility and hysterosalpingography study

Another authorised Phase 3 trial studies infertility in women with unevaluated indications for hysterosalpingography (HSG), which is an X-ray test used to look at the uterus and fallopian tubes.[2] The trial compares oil-based and water-based contrast media during the HSG procedure.[2]

The main outcome is conception leading to live birth, with a positive pregnancy test before the pregnancy, measured within 6 months after randomization.[2] Randomization means participants are assigned by chance to one of the study groups, so the groups can be compared fairly.[2]

Knee osteoarthritis study

The LIPIOJOINT-2 trial is an authorised Phase 3, randomized, sham-controlled, double-blind, multicenter study in people with symptomatic knee osteoarthritis.[3] A sham-controlled study uses a fake procedure for comparison, and double-blind means neither the patient nor the study team knows who received which study treatment during the trial.[3]

This study examines genicular artery embolization, a procedure that aims to block certain knee arteries to reduce symptoms, and compares an ethiodized oil-based emulsion with a sham procedure.[3] The primary endpoint is the change in Visual Analogue Scale (VAS) pain score from randomization to 3 months, where 0 means no pain and 100 means the worst possible pain.[3]

Vascular and kidney safety studies

Two authorised Phase 3 studies focus on vascular procedures and kidney safety in people with peripheral arterial disease or patients undergoing fenestrated endovascular aneurysm repair (FEVAR) for abdominal aortic aneurysm.[4][7] These trials do not mainly test disease treatment; instead, they compare contrast strategies during procedures to see whether kidney-related harm can be reduced.[4][7]

The PeriPREVENT trial studies whether a contrast medium sparing strategy using automated carbon dioxide injection can prevent Major Adverse Kidney Events up to day 90 after infrainguinal peripheral vascular intervention.[4] Its primary outcome is MAKE90, which is a kidney safety measure used to track serious kidney problems after the procedure.[4]

The FEVAR trial compares a strategy that tries to lower iodine contrast exposure by using carbon dioxide when possible during repair of an abdominal aortic aneurysm.[7] Its main outcome is the incidence of acute kidney injury (AKI) in the early postoperative period, measured by the RIFLE classification, a system that grades kidney injury from Risk to End-stage kidney disease.[7]

Cancer imaging study

Two related Phase 2 studies investigate patients with pancreatic cancer and gastroesophageal cancer, which includes esophagus, gastroesophageal junction, and gastric cancer.[5][6] One of these studies was withdrawn, while the other is authorised.[5][6]

These trials study [68Ga]Ga-FAPI total body PET/CT and compare its ability to find suspicious lesions with standard imaging methods such as [18F]FDG PET/CT, CT, and MRI.[5][6] The primary outcome is sensitivity for lesions suspicious of malignancy, measured within 30 minutes after tracer injection.[5][6]

Aneurysm repair study

The authorised low-intervention trial in abdominal aortic aneurysm studies a contrast strategy during fenestrated endovascular aneurysm repair (FEVAR), a procedure used to repair a widened artery in the abdomen.[7] The study compares a carbon dioxide-based contrast-sparing approach with the standard contrast strategy.[7]

The main result is whether the strategy lowers the number of patients with AKI in the early postoperative period, using the RIFLE system to define kidney injury.[7] This makes the study important for understanding whether less iodine contrast exposure can support kidney safety after a complex vascular procedure.[7]

Trial ID Phase Condition studied Status Enrollment
2024-519017-62-00 Phase 2 Breast pathology Authorised 400
2024-512571-12-00 Phase 3 Infertility Authorised 936
NCT06497140 Phase 3 Knee osteoarthritis Authorised 130
2024-512876-37-00 Phase 3 Peripheral arterial disease Authorised 1960
2023-503632-41-00 Phase 2 Pancreatic and gastroesophageal cancer Withdrawn 60
2023-503632-41-01 Phase 2 Pancreatic and gastroesophageal cancer Authorised 90
2025-521795-58-00 Low Intervention Abdominal aortic aneurysm Authorised 243

FAQ

  • What are clinical trials with Iodixanol trying to find out? They are testing how Iodixanol performs in different medical procedures, mainly imaging and vascular studies. The trials look at accuracy, patient outcomes, and safety-related results such as kidney events.
  • Who can take part in these trials? The target groups include people with breast pathology, infertile women, patients with symptomatic knee osteoarthritis, people with peripheral arterial disease, patients with gastroesophageal or pancreatic cancer, and people with abdominal aortic aneurysm. Each trial has its own eligibility rules.
  • What trial phases are listed for Iodixanol studies? Most studies are Phase 2 or Phase 3, and one is listed as Low Intervention. This means the trials are focused on comparing strategies, imaging methods, or outcomes in real patient groups.
  • What kinds of results are measured in these trials? The trials measure outcomes such as lesion detection rate, diagnostic accuracy, live birth after conception, pain score change, major adverse kidney events, and postoperative acute kidney injury. Some studies also measure sensitivity for finding cancer lesions.
  • Is Iodixanol being studied only by itself? No. In these trials, Iodixanol appears as part of contrast media used in imaging or procedures. The studies compare it with other contrast strategies or imaging methods rather than testing it as a stand-alone treatment.

Ongoing Clinical Trials on Iodixanol

  • Study Comparing Oil-Based and Water-Based Contrast Media for Infertility in Women: Iodixanol and Ethyl Esters of Iodised Fatty Acids from Poppyseed Oil

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Effect of Genicular Arteries Embolization with Ioversol and Ethyl Esters of Iodised Fatty Acids in Patients with Symptomatic Knee Osteoarthritis

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on Preventing Kidney Problems in Peripheral Arterial Disease Patients Using Carbon Dioxide and Iopamidol, Iomeprol, and Iopromide During Vascular Procedures

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Iodixanol in Cerebral Angiography for Patients with Unruptured Intracranial Aneurysms

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Carbon Dioxide versus Iodine Contrast in Patients with Abdominal Aortic Aneurysm Having Fenestrated Endovascular Repair

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on Detecting and Classifying Breast Disease Using Iodixanol in Digital Mammography and Tomosynthesis Compared to MRI in Patients with Breast Pathology

    Not yet recruiting

    2 1 1 1
    Investigated drugs:
    Italy

  • Study on [68Ga]Ga-FAPI-46 PET/CT Imaging for Better Diagnosis in Patients with Pancreatic and Gastroesophageal Cancer

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on [68Ga]Ga-FAPI-46 and Iodixanol for Better Imaging in Patients with Pancreatic and Gastroesophageal Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Clinical trial: A planned research study in people. It tests a medical strategy, procedure, or imaging method to see how well it works and how safe or useful it is.
  • Interventional study: A trial where participants receive a planned procedure, test, or treatment so researchers can compare results.
  • Phase 2: A mid-stage trial that usually looks at how well a strategy works and gathers more safety information.
  • Phase 3: A larger trial that compares approaches in many people to confirm benefits and watch for important safety outcomes.
  • Low Intervention: A study with a lower level of added risk because it uses procedures that are already part of regular care or only slightly changed.
  • Primary outcome: The main result the researchers want to measure first. It shows whether the study question was answered.
  • Detection rate: How often a test or imaging method finds a lesion or disease that is present.
  • Diagnostic accuracy: How correctly a test identifies disease and separates it from non-disease.
  • Sensitivity: How well a test finds people who truly have the disease or lesion.
  • Acute kidney injury (AKI): A sudden drop in kidney function. In these trials it is used as an important safety outcome.
  • MAKE90: Major Adverse Kidney Events within 90 days after a procedure. It is a kidney-related safety measure.
  • RIFLE classification: A system used to describe how serious kidney injury is. It includes Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease.

References

  1. https://clinicaltrials.gov/study/2024-519017-62-00
  2. https://clinicaltrials.gov/study/2024-512571-12-00
  3. https://clinicaltrials.eu/trial/study-on-the-effect-of-genicular-arteries-embolization-with-ioversol-and-ethyl-esters-of-iodised-fatty-acids-in-patients-with-symptomatic-knee-osteoarthritis/
  4. https://clinicaltrials.gov/study/2024-512876-37-00
  5. https://clinicaltrials.gov/study/2023-503632-41-00
  6. https://clinicaltrials.gov/study/2023-503632-41-01
  7. https://clinicaltrials.gov/study/2025-521795-58-00