NCT02490696

Brief Summary

The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2015

Typical duration for phase_2 nonsmall-cell-lung-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

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

July 2, 2015

Last Update Submit

July 29, 2020

Conditions

Non-small Cell Lung Cancer

Keywords

PET scanFAZAF-Misohypoxialung cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of hypoxia with FAZA and F-Miso tracer

    SUV max, SUV mean and SUV peak were calculated for FAZA PET and Fmiso PET and will be correlated with results of immunohistochemistry

    one year

Secondary Outcomes (2)

  • overall survival

    one year

  • disease-free survival

    one year

Study Arms (2)

Miso

EXPERIMENTAL

In this arm two PET scans wiil be realized. The first one will be made with F-Miso tracer. 24 hours later the FAZA PET scan will be performed. 24 hours after the last PET scan the surgery will be realized. During this surgery a piece of tumor will be collected and analyse by immunohistochemistry for markers of hypoxia

Device: Miso PET scan

FAZA

EXPERIMENTAL

In this arm two PET scans wiil be realized. The first one will be made with FAZA tracer. 24 hours later the F-Miso PET scan will be performed. 24 hours after the last PET scan the surgery will be realized. During this surgery a piece of tumor will be collected and analyse by immunohistochemistry for markers of hypoxia

Device: FAZA PET scan

Interventions

Miso PET scanDEVICE

2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer

Miso
FAZA PET scanDEVICE

2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer

FAZA

Eligibility Criteria

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

You may qualify if:

  • Male or female
  • More than 18 years old
  • Patient with non-small cell lung cancer (histologically proved)
  • PS inferior or equal to 1 (good general state)
  • Patient must have surgery for their non-small cell lung cancer
  • Stage of tumor Superior or equal to 2a without metastasis
  • Tumoral fixation with 18-FDG-PET superior to mediastinal background noise
  • Written inform consent

You may not qualify if:

  • Histology other than primitive non-small cell lung cancer
  • In situ form at the histological study
  • Patient without evaluable target
  • No fixation on the pretherapeutic FDG-PET scan
  • PS Superior or equal to 2
  • neoplastic disease (less than 2 years or progressive)
  • Pregnant woman or child-bearing
  • Patient Under guardianship or curators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

Related Publications (1)

  • Texte E, Gouel P, Thureau S, Lequesne J, Barres B, Edet-Sanson A, Decazes P, Vera P, Hapdey S. Impact of the Bayesian penalized likelihood algorithm (Q.Clear(R)) in comparison with the OSEM reconstruction on low contrast PET hypoxic images. EJNMMI Phys. 2020 May 12;7(1):28. doi: 10.1186/s40658-020-00300-3.

    PMID: 32399752DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungHypoxiaLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre Vera, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 7, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Study Completion

October 1, 2019

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)