Performance of PET 18 F-FDG Coupled to CT With Contrast Injection Iodized in the Diagnosis of Early Recurrences of Head and Neck Carcinoma Treated With Concurrent Chemoradiation. Comparison With 18F-FDG PET Coupled With CT Not Injected With Filling CT Standard Injection

NCT ID: NCT02510872

Last Updated: 2015-07-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Brief Summary

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Early detection of viable residual tumor or early neoplastic recurrence represents a real challenge in monitoring patients treated with concomitant chemoradiotherapy squamous cell carcinoma of the upper aerodigestive tract.

The locoregional recurrence rate is indeed high (up 40%) over the first two years of this therapeutic method.

The conventional imaging methods such as CT and MRI appear limited in terms of sensitivity because of the many post-treatment changes are fibrosis, tissue edema and the tissue distortion.

PET-CT 18F-FDG proves to be a non-invasive, reliable for the detection of residual tumor and metastasis, even in the absence of clinical signs.

To date, the acquired CT examination in the same time and in the same position that PET is performed without iodinated contrast injection, used for anatomical identification and attenuation correction of PET fused images. The patient usually has a second CT imaging, centered on the neck with contrast injection iodized within the radiology department.

To date, no team has yet studied the interest of the PET-CT 18F-FDG coupled with a CT scan with contrast injection iodized in the diagnosis of early recurrence in head and neck malignancies while interest of the contrast agent injection has been demonstrated in ovarian neoplastic recurrence research, pancreatic and colon.

Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Head and Neck

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FDG PET combined with CT with iodinated contrast injection

18F-FDG PET combined with CT with iodinated contrast injection

Group Type EXPERIMENTAL

18F-FDG PET combined with CT with iodinated contrast injection

Intervention Type OTHER

18F-FDG PET combined with CT without injection

18F-FDG PET combined with CT without injection

Group Type SHAM_COMPARATOR

18F-FDG PET combined with CT without injection

Intervention Type OTHER

Interventions

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18F-FDG PET combined with CT with iodinated contrast injection

Intervention Type OTHER

18F-FDG PET combined with CT without injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged over 18 years
* Squamous cell carcinoma of head and neck
* neoplastic Location: oropharynx, oral cavity, hypopharynx, larynx
* New Patients treated with concomitant radiochemotherapy
* Treatment with chemoradiotherapy ended 3 months ago
* Affiliation to a social security scheme
* Patient who provided written informed consent

Exclusion Criteria

* During Pregnancy or absence of effective contraception in reproductive years
* Breastfeeding
* Creation of a cervical CT with injection of iodinated contrast, in the therapeutic monitoring, dated less than 14 days
* Other history of malignancy, including head and neck carcinomas previously treated outside the basal cell cancer or cervical cancer, treated and cured
* uncontrolled Infectious diseases
* Allergy to iodine
* Severe renal impairment (renal clearance \<30ml / min according to Cockcroft)
* No consent
* Patient deprived of liberty, under guardianship
* Any medical or psychological condition associated that might compromise the patient's ability to participate in the study
* Failure to submit to medical monitoring study for geographical, social or psychic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service Médecine Nucléaire

Caen, , France

Site Status

Countries

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France

Other Identifiers

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10-160

Identifier Type: -

Identifier Source: org_study_id

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