Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Knee osteoarthritis is a common cause of disability in patients who are often young and
      active. Surgery being an option only for the most severe cases, there is little alternative
      in case of failure of recommended medication. Inflammatory hypervascularization of the joint
      is a known source of pain. Temporary embolization of intra-arterial inflammatory
      hypervascularization has been used since 2012 with good results on pain relief to treat
      patients with musculoskeletal disorders that are resistant to conventional treatments.
      Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has
      been used as an emulsion with chemotherapy for the treatment of metastases and primary
      intra-arterial liver cancer (chemo-embolization) for many years without serious side effects.
      We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for
      the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders
      in humans.
    

Detailed description: 
      It is a Phase 1, Single-Arm, Open-label, Multicenter Interventional Prospective Study.

      In order to ensure the best possible patient safety, a sequential inclusion of the first 6
      patients is planned. Thus, the inclusion of each subsequent patient (patient 2-6) will only
      be considered after reviewing previously included patient safety data. Safety data after the
      inclusion of each patient (after a step-back of at least one week), as well as the cumulative
      review of previously included patient safety data, will be brought to the attention of all
      investigators involved in this research.

      In addition, the following information will be transmitted to the Competent Authority without
      delay:

        -  a review of the safety and efficacy of the first 3 patients included with a step back
           for the last patient of at least one week after the administration of the experimental
           drug, as well as an argument as to the continuation of this research with regard to
           these data, with a discussion of the risks incurred in relation to the expected profit

        -  a review of the safety and effectiveness of the first 3 patients after the inclusion of
           the first 6 patients, as well as an argument as to the continuation of this research
           with regard to these data, with a discussion of the risks incurred compared to the
           expected benefit.

      The patients will be embolized by the Interventional Radiology Department of the European
      Hospital Georges Pompidou (HEGP). Embolization will be performed by an experienced
      radiologist during a conventional hospitalization or a day hospitalization. A clinical
      follow-up will be carried out at 1 week, 1 month and 3 months after embolization by clinics
      and patient self-assessment (WOMAC, SF-36).
    

Intervention name(s): Lipiodol
Intervention type(s): Drug
Intervention description(s): Lipiodol in emulsion with contrast agent
Other intervention name(s): Optiray
Intervention MeSH terms: Ethiodized Oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipiodol; musculoskeletal disorders; embolization