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

France75 participantsStarted 2019-06-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

diagnosis performance of 18-FDG PET-CT

Timeframe: up to 3 months

Trial details

NCT IDNCT04826445

SponsorGustave Roussy, Cancer Campus, Grand Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06

Contact for this trial

Aina DINNOO, MD

0142114211 ainia.dinnoo@gustaveroussy.fr

View on ClinicalTrials.gov More Mandibular Osteoradionecrosis trials