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NCT04031534 Clinical Trial

Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma

Squamous Cell Carcinoma of the Oropharynx Clinical Trial

— HYPONECK  

Official title:
Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04031534
Other study ID # CHB16.03
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 21, 2019
Est. completion date March 2022

Study information
Verified date July 2020
Source Centre Henri Becquerel
Contact Sebastien Thureau, MD, PhD
Phone +33232082992
Email sebastien.thureau@chb.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 2022
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient with squamous cells carcinoma of oropharynx

- Age Superior to 10 years old

- Male or Female

- measurable target according RECIST criteria

Exclusion Criteria:

- -Other histologic cancer than squamous cells carcinoma of oropharynx

- No measurable target

- Presence of metastasis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• F-Miso PET scan coupled with MRI
Patient will undergo F-Miso PET and MRI before surgery for their head and neck cancer. Hypoxia detect with imaging will be correlated with hypoxia detected by immunohistochemistry on tumour biopsy

Locations
Country Name City State
France Centre Henri Becquerel Rouen

Sponsors (1)
Lead Sponsor Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx 1 year
Secondary Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia 1 year
Secondary Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC) 1 year
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