USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY

  • STATUS
    Recruiting
  • End date
    Jun 10, 2024
  • participants needed
    75
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 10 April 2021

Summary

This study is created in order to refine and reduce the duration between the medical and surgical therapeutic sequences (when the surgery is necessary) in these fragile patients knowing that conventional radiological changes can only be observed with a delay comprised between 3 and 6 months starting from observed clinical changes.

Details
Condition Mandibular Osteoradionecrosis
Treatment Data Collection
Clinical Study IdentifierNCT04826445
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on10 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with symptomatic osteoradionecrosis with a PENTOCLO protocol indication (decided in a multi-disciplinary staff)
Patient should understand to any protocol-specific procedures performed. Patient who did not object to participate after being informed of the study. Patient should be able and willing to comply with study visits and procedures as per protocol
Patients must be affiliated to a social security system or beneficiary of the same
Patients must be over 18 years old (legal age)

Exclusion Criteria

Excluded forms of the disease: mandibular osteoradionecrosis complicated by mandibular fracture and / or hyperalgesic (resistant to analgesic treatment of stage III)
Contraindications specific to the treatment under study (allergy to one of the PENTOCLO treatments, contraindication to 18FDG PET-CT)
Associated pathology that contra-indicate on of the PENTOCLO treatment
Pregnant woman, declaring likely to be pregnant or breastfeeding. Chilbearing age women must declare not being pregnant and use effective contraception
Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons
Patient under guardianship or deprived of his liberty by a judicial or administrative decision or unable to express its opposition to participating in the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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