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

• Conditions: Mandibular Osteoradionecrosis
• Interventions: Other: Data collection

• Registration Number: NCT04826445
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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 conventional radiological changes can only be observed with a delay comprised between 3 and 6 months starting from observed clinical changes.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-11
• Status Verified: 2021-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Patients with symptomatic osteoradionecrosis with a PENTOCLO protocol indication (decided in a multi-disciplinary staff).
2. 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.
3. Patients must be affiliated to a social security system or beneficiary of the same.
4. Patients must be over 18 years old (legal age).

Exclusion Criteria

1. Excluded forms of the disease: mandibular osteoradionecrosis complicated by mandibular fracture and / or hyperalgesic (resistant to analgesic treatment of stage III).
2. Contraindications specific to the treatment under study (allergy to one of the PENTOCLO treatments, contraindication to 18FDG PET-CT).
3. Associated pathology that contra-indicate on of the PENTOCLO treatment.
4. Pregnant woman, declaring likely to be pregnant or breastfeeding. Chilbearing age women must declare not being pregnant and use effective contraception.
5. Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons.
6. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients included in PENTOCLO protocol	Data collection	We perform a prospective study with inclusions of all consecutive patients with osteoradionecrosis eligible for PENTOCLO.

Primary Outcome Measures

Name	Time	Method
diagnosis performance of 18-FDG PET-CT	up to 3 months	Evaluate the diagnosis performance of 18-FDG PET-CT with the criteria of Mandibular mean FDG uptake compared between the reference test and at 3 months: ΔSUVmean

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France