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

NCT04826445 | Unknown

• 2 other identifiers: 2019-A00965-522019/2931
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Osteoradionecrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients included in PENTOCLO protocol

We perform a prospective study with inclusions of all consecutive patients with osteoradionecrosis eligible for PENTOCLO.

Other: Data collection

Interventions

Data collection OTHER

Imaging collection

Patients included in PENTOCLO protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with mandibular osteoradionecrosis treated in the PENTOCLO protocol

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Aina DINNOO, MD

CONTACT

0142114211; ainia.dinnoo@gustaveroussy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: June 11, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (1)