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

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.

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Médecine Nucléaire

Caen, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

18F-FDG PET combined with CT without injection

Other

Primary outcomes

ratio of false positive rate of 2 compared strategies

Time frame: baseline

Final classification review (Benin, malignant or suspicious)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: TEPVAD

Important dates

Study start: 2011
Primary completion: 2014
First posted: Jul 29, 2015
Registry last updated: Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed