Measurement of Head and Neck Tumor Hypoxia With PET-MRI

NCT05246475 | Recruiting

• 1 other identifier: T255/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• PET-MRI correlation

  Voxel level correlation of DW-MRI and PET estimates

  1 day

Study Arms (1)

PET-MRI

EXPERIMENTAL

Simultaneous 18F-EF5 PET and DW-MRI

Diagnostic Test: PET-MRI

Interventions

PET-MRI DIAGNOSTIC_TEST

Simultaneous PET-MRI measurement

PET-MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, G102881, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jussi Hirvonen, MD, PhD

  Radiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi Hirvonen, MD, PhD

CONTACT

0035823130000; jussi.hirvonen@tyks.fi

Antti Silvoniemi, MD, PhD

CONTACT

0035823130000; antti.silvoniemi@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist

Model Details: Patients will be scanned with both MRI and PET.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: February 8, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)