Status:
UNKNOWN
USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Mandibular Osteoradionecrosis
Eligibility:
All Genders
18+ years
Brief 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 conventio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04826445
Start Date
June 11 2019
End Date
June 1 2024
Last Update
April 1 2021
Active Locations (1)
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1
Gustave Roussy
Villejuif, France, 94800