Comparison of Tumor Glucose Metabolism Before and After A... | NCT02382237

Studies
Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition

NCT02382237

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Status

Completed

Last Update Posted

Aug 21, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Head and Neck Cancer
Oesophageal Cancer

Interventions

PET/TDM

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Nov 2015Actual

Completion Date

Aug 9, 2017Actual

First Submitted Date

Feb 4, 2014

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2017

Last Update Posted Date

Aug 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PET/TDM	Other	Evaluation by PET/TDM at 2 times	Device: PET/TDM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/TDM	Device	Evaluation of nutrition absorption by TEP/TDM	PET/TDM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

VADS cancer or oesophageal cancer
Evaluation by 18F-FDG PET
denutrition with weight loss of 5%
Artificial nutrition
ECOG<2

Exclusion Criteria:

Treatment by chemotherapy, surgery unless 2 months
Treatment by radiotherapy unless 4 months
Capillar glycemia >12mmol/l during the PET

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DESHAYES Emmanuel	ICM Co. Ltd.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ICM Val d'Aurelle		Montpellier		34298	France

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D005248	Feeding Methods

Browse Leaves

Not provided

Browse Branches

Not provided