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Measurement of Head and Neck Tumor Hypoxia With PET-MRI (EF5NECK)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
PET-MRI
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18 to 80 years old
  • Sex: male or female
  • Language spoken: Finnish or Swedish
  • Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
  • Mental status: Patients must be able to understand the meaning of the study
  • Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck (oral cavity, pharynx or larynx)
  • Primary tumor diameter as determined clinically or from contrast enhanced CT or MRI scan must be at least 20 mm
  • Patients with nodal neck metastases of head and neck cancer are eligible
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
  • Gravidity: Patient, if female, must not be pregnant or lactating at the time of the study

Exclusion Criteria:

  • Any previously known contraindication of MR Imaging (including but not limited to metallic implants or foreign bodies, pacemakers or other cardiac implantable electronic devices, MR-incompatible prosthetic heart valves, contrast allergy, claustrophobia)
  • Prior Medical History: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Since none of these is an absolute contraindication for inclusion final judgement will be left to the investigators.
  • Prior Therapy: Patient must have no history of previous chemotherapy, biological therapy, immunotherapy, radiotherapy or major surgery for treatment of head and neck cancer
  • Infections: Patient must not have an uncontrolled serious infection
  • Advanced disease: Patient is not eligible for curative cancer treatment due to advanced disease.

Sites / Locations

  • Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET-MRI

Arm Description

Simultaneous 18F-EF5 PET and DW-MRI

Outcomes

Primary Outcome Measures

PET-MRI correlation
Voxel level correlation of DW-MRI and PET estimates

Secondary Outcome Measures

Full Information

First Posted
February 8, 2022
Last Updated
February 8, 2022
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05246475
Brief Title
Measurement of Head and Neck Tumor Hypoxia With PET-MRI
Acronym
EF5NECK
Official Title
Simultaneous PET-MRI for Comparison of Advanced DW-MRI Techniques and EF5-PET in the Detection of Hypoxia in Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

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
This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using [18F]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Therefore, a clinically applicable method to detect tumor hypoxia is of great importance.
Detailed Description
This is a non-randomized prospective study which aims to compare [18F]EF5 PET data and MR imaging data acquired with simultaneous PET/MR imaging. Hypoxic tumor tends to be more aggressive than its non-hypoxic counterpart since hypoxia promotes invasive tumor growth and metastatic spread of the disease. The detrimental effect of hypoxia on outcome of radiotherapy (RT) is especially important in head and neck cancer. EF5 is a comprehensively studied hypoxia-avid compound, which is utilized in radiolabeled form in [18F]EF5 PET imaging detecting tumor hypoxia. IVIM (intra-voxel incoherent motion) is novel technique based on diffusion-weighted MRI (DWI), which allows for the distinction between tissue perfusion and diffusion without the need for intravenous contrast agent. This study aims to investigate the potential of novel MRI techniques for tumor hypoxia assessment in HNC. The specific aims of the current study are: To characterize the voxel-level relationship between diffusion characteristics in tumor tissue, as measured with DW-MRI, and tumor hypoxia, as measured with [18F]EF5-PET, leveraging the state-of-the-art simultaneous MRI/PET measurement; To employ IVIM-based modeling of DW-MRI signal using multiple b-values to optimize the diffusion metrics that most closely predict tumor hypoxia, and compare those with the perfusion metrics from DCE; To develop models based on novel radiophenotypic analyses of MRI data (radiomics) and machine learning algorithms to find MRI patterns that best predict tumor hypoxia at the patient sample level. The only intervention for participating subjects is an additional [18F]EF5-PET/MR scan, which is not used for any clinical purposes. All study subjects will undergo standard diagnostic and treatment procedures according to clinical routine. A standard dose of about 300 MBq of the radiotracer [18F]EF5 will be administered intravenously via an upper extremity vein. About 180 min after tracer injection, radioactivity will be followed in the neck area with the PET/MRI device for about 20 min. [18F]EF5 uptake will be modeled as standard uptake value (SUV), and tumor-to-background ratios (TBR) will be calculated. The MRI protocol will include anatomical sequences covering the primary tumor as well as the neck for lymph node metastases. Several DW-MRI methods will also be employed. In total, MRI experiments will be completed in about 1 hour.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will be scanned with both MRI and PET.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET-MRI
Arm Type
Experimental
Arm Description
Simultaneous 18F-EF5 PET and DW-MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
PET-MRI
Intervention Description
Simultaneous PET-MRI measurement
Primary Outcome Measure Information:
Title
PET-MRI correlation
Description
Voxel level correlation of DW-MRI and PET estimates
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 to 80 years old Sex: male or female Language spoken: Finnish or Swedish Performance status: Karnofsky score 70 or better or WHO performance status 2 or better Mental status: Patients must be able to understand the meaning of the study Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck (oral cavity, pharynx or larynx) Primary tumor diameter as determined clinically or from contrast enhanced CT or MRI scan must be at least 20 mm Patients with nodal neck metastases of head and neck cancer are eligible Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff Gravidity: Patient, if female, must not be pregnant or lactating at the time of the study Exclusion Criteria: Any previously known contraindication of MR Imaging (including but not limited to metallic implants or foreign bodies, pacemakers or other cardiac implantable electronic devices, MR-incompatible prosthetic heart valves, contrast allergy, claustrophobia) Prior Medical History: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Since none of these is an absolute contraindication for inclusion final judgement will be left to the investigators. Prior Therapy: Patient must have no history of previous chemotherapy, biological therapy, immunotherapy, radiotherapy or major surgery for treatment of head and neck cancer Infections: Patient must not have an uncontrolled serious infection Advanced disease: Patient is not eligible for curative cancer treatment due to advanced disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jussi Hirvonen, MD, PhD
Phone
0035823130000
Email
jussi.hirvonen@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Antti Silvoniemi, MD, PhD
Phone
0035823130000
Email
antti.silvoniemi@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jussi Hirvonen, MD, PhD
Organizational Affiliation
Radiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
G102881
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jussi Hirvonen, MD, PhD
Phone
0035823130000
Email
jussi.hirvonen@tyks.fi
First Name & Middle Initial & Last Name & Degree
Antti Silvoniemi, MD, PhD
Phone
0035823130000
Email
antti.silvoniemi@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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Measurement of Head and Neck Tumor Hypoxia With PET-MRI

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