Squamous Cell Carcinoma of the Head and NeckTEPVADNCT02510872
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
A study testing 18F-FDG PET combined with CT with iodinated contrast injection and 18F-FDG PET combined with CT without injection in people with Squamous Cell Carcinoma of the Head and Neck, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- 18F-FDG PET combined with CT with iodinated contrast injection and 18F-FDG PET combined with CT without injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- 18F-FDG PET combined with CT with iodinated contrast injection, 18F-FDG PET combined with CT without injection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET combined with CT with iodinated contrast injectionOther
18F-FDG PET combined with CT without injectionOther
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG PET combined with CT with iodinated contrast injection | Experimental | 18F-FDG PET combined with CT with iodinated contrast injection Receives: 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 Receives: Other: 18F-FDG PET combined with CT without injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of false positive rate of 2 compared strategies
Final classification review (Benin, malignant or suspicious)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startDec 2011
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510872
- Sponsor's protocol ID
- 10-160
- Acronym
- TEPVAD
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02510872
- Acronym / sponsor ID
- TEPVAD / 10-160
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET combined with CT with iodinated contrast injection | Experimental | Other: 18F-FDG PET combined with CT with iodinated contrast injection18F-FDG PET combined with CT with iodinated contrast injection |
| 18F-FDG PET combined with CT without injection | Sham comparator | Other: 18F-FDG PET combined with CT without injection18F-FDG PET combined with CT without injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
ratio of false positive rate of 2 compared strategies
Time frame: baseline
Final classification review (Benin, malignant or suspicious)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET combined with CT with iodinated contrast injection and 18F-FDG PET combined with CT without injection in people with Squamous Cell Carcinoma of the Head and Neck, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio of false positive rate of 2 compared strategies (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.