NCT02382237

Brief Summary

Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

February 4, 2014

Last Update Submit

August 16, 2017

Conditions

Head and Neck CancerOesophageal Cancer

Keywords

denutrition in Head and Neck cancer or oesophageal cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

PET/TDM

OTHER

Evaluation by PET/TDM at 2 times

Device: PET/TDM

Interventions

PET/TDMDEVICE

Evaluation of nutrition absorption by TEP/TDM

Also known as: Parenteral or enteral nutrition
PET/TDM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICM Val d'Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsEsophageal Neoplasms

Interventions

InjectionsEnteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsFeeding MethodsNutritional SupportNutrition Therapy

Study Officials

  • DESHAYES Emmanuel

    ICM Co. Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2014

First Posted

March 6, 2015

Study Start

October 1, 2013

Primary Completion

November 1, 2015

Study Completion

August 9, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

FR(1)