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

Phase 2

• Conditions: Squamous Cell Carcinoma of the Oropharynx
• Interventions: Drug: F-Miso PET scan coupled with MRI

• Registration Number: NCT04031534
• Lead Sponsor: Centre Henri Becquerel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-21
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30
• Primary Completion: 2021-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measure of hypoxia by F-Miso PET scan and RMI	F-Miso PET scan coupled with MRI	Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia	1 year
Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC)	1 year

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France