NCT01261585

Brief Summary

Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG), fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT) measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer. This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung. The investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

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

December 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
Last Updated

December 16, 2010

Status Verified

January 1, 2009

Enrollment Period

11 months

First QC Date

December 15, 2010

Last Update Submit

December 15, 2010

Conditions

Keywords

Positron-Emission TomographyPET ScanFDGFLTFMISONon-Small-Cell Lung Carcinomachemo-Radiation OncologySUV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diagnosed patients with non-small-cell lung carcinoma

You may qualify if:

  • patients with non-small-cell lung carcinoma hitologicaly proved
  • Candidate patients in a treatment with aim guardian by exclusive thoracic radiotherapy or of concomitant radiochemotherapy (tumoral dose superior to 60 Gy) ( n=5 ).
  • Measurable tumor according to the criteria of evaluation RECIST

You may not qualify if:

  • Histology other one than primitive bronchial cancer not in small cells lung
  • The patients for whom no tumoral target is assessable (forgiveness completes after first chemotherapy, operated patients).
  • Patients for whom a radiotherapy with curative aim is not indicated (tumoral extension, metastases, general state, co-morbidity).
  • Patient having benefited from an examination PET in the FDG with in more than 4 weeks and for which a new PET in the FDG is not necessary with in the framework of its disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, Hate Normandie, 76000, France

Location

Related Publications (2)

  • Ganem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2.

  • Calais J, Thureau S, Dubray B, Modzelewski R, Thiberville L, Gardin I, Vera P. Areas of high 18F-FDG uptake on preradiotherapy PET/CT identify preferential sites of local relapse after chemoradiotherapy for non-small cell lung cancer. J Nucl Med. 2015 Feb;56(2):196-203. doi: 10.2967/jnumed.114.144253. Epub 2015 Jan 8.

MeSH Terms

Conditions

Bronchial NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsBronchial DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicLung Diseases

Study Officials

  • GUERNOU Mohamed, MD

    CHBecquerel

    PRINCIPAL INVESTIGATOR
  • VERA Pierre, MD phD

    CHBecquerel

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 16, 2010

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

December 16, 2010

Record last verified: 2009-01

Locations