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

NCT02510872 | Completed

• 1 other identifier: 10-160
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• ratio of false positive rate of 2 compared strategies

  Final classification review (Benin, malignant or suspicious)

  baseline

Study Arms (2)

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

EXPERIMENTAL

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

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

18F-FDG PET combined with CT without injection

SHAM COMPARATOR

18F-FDG PET combined with CT without injection

Other: 18F-FDG PET combined with CT without injection

Interventions

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

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

18F-FDG PET combined with CT without injection OTHER

18F-FDG PET combined with CT without injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Service Médecine Nucléaire

Caen, 14000, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 29, 2015
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

FR (1)