NCT04031534

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2019

Typical duration for phase_2

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

March 21, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

July 19, 2019

Last Update Submit

December 29, 2025

Conditions

Squamous Cell Carcinoma of the Oropharynx

Keywords

F-Miso PET scanMagnetic resonance imagingimmunohistochemistryHead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Measure of hypoxia by F-Miso PET scan and RMI

EXPERIMENTAL

Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy

Drug: F-Miso PET scan coupled with MRI

Interventions

F-Miso PET scan coupled with MRIDRUG

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

Measure of hypoxia by F-Miso PET scan and RMI

Eligibility Criteria

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

You may qualify if:

  • Patient with squamous cells carcinoma of oropharynx
  • Age Superior to 10 years old
  • Male or Female
  • measurable target according RECIST criteria

You may not qualify if:

  • Other histologic cancer than squamous cells carcinoma of oropharynx
  • No measurable target
  • Presence of metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sebastien Thureau, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 24, 2019

Study Start

March 21, 2019

Primary Completion

August 6, 2021

Study Completion

July 21, 2022

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)