Back to resultsStudy of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma (HYPONECK)
Primary Purpose
Squamous Cell Carcinoma of the Oropharynx
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
F-Miso PET scan coupled with MRI
Sponsored by
About this trial
This is an interventional other trial for Squamous Cell Carcinoma of the Oropharynx focused on measuring F-Miso PET scan, Magnetic resonance imaging, immunohistochemistry, Head and neck cancer
Eligibility Criteria
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
Sites / Locations
- Centre Henri BecquerelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Measure of hypoxia by F-Miso PET scan and RMI
Arm Description
Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy
Outcomes
Primary Outcome Measures
Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx
Secondary Outcome Measures
Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia
Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04031534
Brief Title
Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma
Acronym
HYPONECK
Official Title
Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oropharynx
Keywords
F-Miso PET scan, Magnetic resonance imaging, immunohistochemistry, Head and neck cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Measure of hypoxia by F-Miso PET scan and RMI
Arm Type
Experimental
Arm Description
Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy
Intervention Type
Drug
Intervention Name(s)
F-Miso PET scan coupled with MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia
Time Frame
1 year
Title
Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastien Thureau, MD, PhD
Phone
+33232082992
Email
sebastien.thureau@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Thureau, MD, PhD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien Thureau, Md, PhD
Phone
+33232082992
Email
sebastien.thureau@chb.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma
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