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Trial record 1 of 1 for:    LipioJoint 1
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Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1) (LipioJoint1)

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ClinicalTrials.gov Identifier: NCT04733092
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : May 13, 2022
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Lipiodol Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of the Safety and Efficacy of the Use of a Lipiodol Emulsion for the Embolization of Inflammatory Hypervascularizations Observed in Patients With Joint or Abarticular Knee Pain
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Embolization
Embolization of the inflammatory hypervascularization with a lipiodol emulsion
Drug: Lipiodol
Lipiodol in emulsion with contrast agent
Other Name: Optiray




Primary Outcome Measures :
  1. Serious Adverse Events (SAE) [ Time Frame: 1 month ]
    Number of SAE related to Embolization


Secondary Outcome Measures :
  1. Immediate Technical success [ Time Frame: Intraoperative ]
    Success of catheterization and embolization of target hypervascularization

  2. Pain improvement 1 week after embolization [ Time Frame: 1 week ]
    Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)

  3. Pain improvement 1 month after embolization [ Time Frame: 1 month ]
    Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)

  4. Pain improvement 3 month after embolization [ Time Frame: 3 months ]
    Analog Visual Scale score (0-100) comparison to baseline VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patients marks. The Scale is rated from 0 to 100 (no pain to extremely severe pain)

  5. Articular impotence improvement 1 week after embolization [ Time Frame: 1 week ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline

  6. Articular impotence improvement 1 month after embolization [ Time Frame: 1 month ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline

  7. Articular impotence improvement 3 month after embolization [ Time Frame: 3 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (0-96) comparison to baseline

  8. Quality of life improvement 3 month after embolization [ Time Frame: 3 months ]
    Short Form Health Survey (SF-36) score comparison to baseline SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  9. Pain medication improvement 1 week after embolization [ Time Frame: 1 week ]
    Dose of analgesic medication compared to baseline (mg/24h)

  10. Pain medication improvement 1 month after embolization [ Time Frame: 1 month ]
    Dose of analgesic medication compared to baseline (mg/24h)

  11. Pain medication improvement 3 month after embolization [ Time Frame: 3 months ]
    Dose of analgesic medication compared to baseline (mg/24h)

  12. Patient's satisfaction [ Time Frame: 3 months ]
    Patient's satisfaction questionnaire : qualitative questionnaire with 5 ordered modalities (0 = no to 4 = yes)

  13. Adverse Events (AE) [ Time Frame: 3 months ]
    Number of AE related to embolization

  14. Serious Adverse Events (SAE) [ Time Frame: 3 months ]
    Number of SAE related to embolization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a knee osteoarthritis according to the American College of Rheumatology (ACR) classification and a score ≥ 2 according to the classification of Kellgren and Lawrence
  • Patient not eligible for surgery (or refusing surgery)
  • Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3 months
  • Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen, and/or failure or intolerance or patient refusing strong opioids medication (morphine, codeine)
  • Failure or patient refusal of corticosteroid infiltration
  • Patient who has signed an informed consent

Exclusion Criteria:

  • Patient who is unable or unable to comply with the follow-up schedule
  • Infiltration of target joint less than three months old
  • Treated hyperthyroidism
  • Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint
  • Known arterial disease of the lower limbs stage ≥ 2 according to the classification of Leriche and Fontaine
  • Known severe allergy to Lipiodol® and/or iodized contrast product
  • Known severe kidney failure (creatinine clearance < 30 ml/min)
  • Pregnant or breastfeeding woman
  • Patient not affiliated with a French Medicare
  • Patient benefiting from legal protection
  • Participation in another interventional research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04733092


Contacts
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Contact: Marc MD Sapoval, PhD 01 56 09 37 40 marc.sapoval2@aphp.fr
Contact: Cléo Bourgeois 01 56 09 56 38 cleo.bourgeois@aphp.fr

Locations
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France
Hôpital européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Marc MD Sapoval, PhD    01 56 09 37 40    marc.sapoval2@aphp.fr   
Contact: Carole Dean    01 56 09 37 19    carole.dean@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Guerbet
Investigators
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Principal Investigator: Marc MD Sapoval, PhD AP-HP, Hôpital Européen Georges Pompidou, Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04733092    
Other Study ID Numbers: APHP190891
2020-002206-10 ( EudraCT Number )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 2 years after the last publication
Access Criteria:

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.

Data sharing must respect the agreements made with funders.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contracting


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lipiodol
musculoskeletal disorders
embolization
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ethiodized Oil
Antineoplastic Agents