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 (TEPVAD)

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.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Other: 18F-FDG PET combined with CT with iodinated contrast injection; Other: 18F-FDG PET combined with CT without injection

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Service Médecine Nucléaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-FDG PET combined with CT with iodinated contrast injection	Other: 18F-FDG PET combined with CT with iodinated contrast injection
Sham Comparator: 18F-FDG PET combined with CT without injection	Other: 18F-FDG PET combined with CT without injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio of false positive rate of 2 compared strategies	Final classification review (Benin, malignant or suspicious)	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 29, 2015

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 10-160