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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)

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-FDG PET combined with CT with iodinated contrast injection
18F-FDG PET combined with CT without injection
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service Médecine Nucléaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

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

18F-FDG PET combined with CT without injection

Arm Description

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

18F-FDG PET combined with CT without injection

Outcomes

Primary Outcome Measures

ratio of false positive rate of 2 compared strategies
Final classification review (Benin, malignant or suspicious)

Secondary Outcome Measures

Full Information

First Posted
July 27, 2015
Last Updated
July 27, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02510872
Brief Title
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
Acronym
TEPVAD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG PET combined with CT with iodinated contrast injection
Arm Type
Experimental
Arm Description
18F-FDG PET combined with CT with iodinated contrast injection
Arm Title
18F-FDG PET combined with CT without injection
Arm Type
Sham Comparator
Arm Description
18F-FDG PET combined with CT without injection
Intervention Type
Other
Intervention Name(s)
18F-FDG PET combined with CT with iodinated contrast injection
Intervention Type
Other
Intervention Name(s)
18F-FDG PET combined with CT without injection
Primary Outcome Measure Information:
Title
ratio of false positive rate of 2 compared strategies
Description
Final classification review (Benin, malignant or suspicious)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service Médecine Nucléaire
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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