search
Back to results

Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition (PETANC)

Primary Purpose

Head and Neck Cancer, Oesophageal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET/TDM
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring denutrition in Head and Neck cancer or oesophageal cancer

Eligibility Criteria

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

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

Sites / Locations

  • ICM Val d'Aurelle

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET/TDM

Arm Description

Evaluation by PET/TDM at 2 times

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 4, 2014
Last Updated
August 16, 2017
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
search

1. Study Identification

Unique Protocol Identification Number
NCT02382237
Brief Title
Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition
Acronym
PETANC
Official Title
Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition Assessed by F-FDG Petscan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oesophageal Cancer
Keywords
denutrition in Head and Neck cancer or oesophageal cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/TDM
Arm Type
Other
Arm Description
Evaluation by PET/TDM at 2 times
Intervention Type
Device
Intervention Name(s)
PET/TDM
Other Intervention Name(s)
Parenteral or enteral nutrition
Intervention Description
Evaluation of nutrition absorption by TEP/TDM
Primary Outcome Measure Information:
Title
rate of Standardized Uptake Value (SUV)
Description
The variation of the SUVmax is defined as the difference of the tumoral SUV max between the TEP1 and the TEP2
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DESHAYES Emmanuel
Organizational Affiliation
ICM Co. Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICM Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Learn more about this trial

Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition

We'll reach out to this number within 24 hrs