Head and Neck CancerPETANCNCT02382237
Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition
A study testing PET/TDM in people with Head and Neck Cancer and Oesophageal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oesophageal Cancer
- What is being tested?
- PET/TDM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to 9 Aug 2017
- 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
- VADS cancer or oesophageal cancer
- Evaluation by 18F-FDG PET
- denutrition with weight loss of 5%
- Artificial nutrition
- ECOG<2
Who cannot join
- Treatment by chemotherapy, surgery unless 2 months
- Treatment by radiotherapy unless 4 months
- Capillar glycemia >12mmol/l during the PET
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition Assessed by F-FDG Petscan
Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.
Read the detailed description
Evaluation of the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. This activity will be measured with TEP/TDM 18F-FDG
- Conditions
- Head and Neck Cancer, Oesophageal Cancer
- Being tested
- PET/TDM
- Keywords
- denutrition in Head and Neck cancer or oesophageal cancer
- Medical subject headings
- Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/TDMDevice
Also called Parenteral or enteral nutrition
Evaluation of nutrition absorption by TEP/TDM
| Study group | Role | What they receive |
|---|---|---|
| PET/TDM | Other | Evaluation by PET/TDM at 2 times Receives: Device: PET/TDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of Standardized Uptake Value (SUV)
The variation of the SUVmax is defined as the difference of the tumoral SUV max between the TEP1 and the TEP2
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DESHAYES Emmanuel, Principal investigator, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382237
- Sponsor's protocol ID
- ICM2013/31
- Acronym
- PETANC
- Status last verified
- Aug 2017
- First submitted
- 4 Feb 2014
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition Assessed by F-FDG Petscan
- ClinicalTrials.gov ID
- NCT02382237
- Acronym / sponsor ID
- PETANC / ICM2013/31
- Conditions
- Head and Neck Cancer, Oesophageal Cancer
- Keywords
- denutrition in Head and Neck cancer or oesophageal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 6 Mar 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.
Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.
Detailed description
Evaluation of the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. This activity will be measured with TEP/TDM 18F-FDG
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/TDM | Other | Device: PET/TDMEvaluation by PET/TDM at 2 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- VADS cancer or oesophageal cancer
- Evaluation by 18F-FDG PET
- denutrition with weight loss of 5%
- Artificial nutrition
- ECOG<2
Key exclusion criteria (3 listed)
- Treatment by chemotherapy, surgery unless 2 months
- Treatment by radiotherapy unless 4 months
- Capillar glycemia >12mmol/l during the PET
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 |
|---|---|---|
| PET/TDMAlso: Parenteral or enteral nutritionEvaluation of nutrition absorption by TEP/TDM | Device | PET/TDM |
Primary outcome
rate of Standardized Uptake Value (SUV)
Time frame: 3 months
The variation of the SUVmax is defined as the difference of the tumoral SUV max between the TEP1 and the TEP2
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 21 Aug 2017.
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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.
DESHAYES Emmanuel principal investigator
ICM Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/TDM in people with Head and Neck Cancer and Oesophageal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 5 inclusion and 3 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 21 Aug 2017. 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. 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?
rate of Standardized Uptake Value (SUV) (time frame: 3 months). 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 21 Aug 2017.