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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-11

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer

NCT03053960

Oral Cavity Squamous Cell Carcinoma

TERMINATED

18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study

NCT02938546

Non-small-cell Lung Cancer

UNKNOWN PHASE3

Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by FDG-PET and Molecular Markers

NCT02600442

Breast Neoplasms Breast Cancer

UNKNOWN

Evaluation of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma

NCT03636945

Medullary Thyroid Carcinoma

UNKNOWN NA

F-18 PET Bone Scans Versus Tc-99m Bone Scans for the Diagnosis of Bone Metastases

NCT01254929

Cancer Bone Metastases

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mandibular Osteoradionecrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients included in PENTOCLO protocol

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

Data collection

Intervention Type OTHER

Imaging collection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data collection

Imaging collection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No