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

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.

Study Overview

• Status: Recruiting
• Conditions: Mandibular Osteoradionecrosis
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Aina DINNOO, MD; Phone Number: +33 0142114211; Email: ainia.dinnoo@gustaveroussy.fr

Study Locations

• France
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
    • Contact: Aina Dinnoo, MD; Phone Number: +33 0142114211; Email: aina.dinnoo@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with mandibular osteoradionecrosis treated in the PENTOCLO protocol

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients included in PENTOCLO protocol; We perform a prospective study with inclusions of all consecutive patients with osteoradionecrosis eligible for PENTOCLO.	Other: Data collection; Imaging collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis performance of 18-FDG PET-CT	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	up to 3 months

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2019
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries; Osteoradionecrosis
• Other Study ID Numbers: 2019-A00965-52; 2019/2931 (OTHER: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No