ClinicalTrials.gg
Status unknownNCT04826445PENTOTEPUpdated Apr 1, 2021

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

An observational study in Mandibular Osteoradionecrosis, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Mandibular Osteoradionecrosis

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03

In context

Osteoradionecrosis

24 studies on the registry are indexed under Osteoradionecrosis; 8 are open to participants now.

This study's planned enrollment of 75 is below the median of 140 across 10 observational studies indexed under Osteoradionecrosis.

Browse Osteoradionecrosis studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 245 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with mandibular osteoradionecrosis treated in the PENTOCLO protocol

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. 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 .
  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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherData collection

    Imaging collection

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What researchers measure

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

    Time frame: up to 3 months

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04826445
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Jun 11, 2019
Primary completion
Jun 2022 (estimated)
Completion
Jun 2024 (estimated)
Last update
Apr 1, 2021

Study contacts

Aina DINNOO, MD
Contact
ainia.dinnoo@gustaveroussy.fr
0142114211 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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