PET/MR in Radiotherapy for Head and Neck Cancer Pilot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a pilot non-intervention study that aims to introduce PET/MRI, a state of the art new imaging technique, into the radiotherapy treatment pathway of patients with head and neck cancer. Ultimately the investigators aim to establish appropriate scanning and image registration protocols, to allow progression to a randomized trial of adaptive radiotherapy dose escalation. The latter is thought to potentially improve outcomes in this group.

Ten patients with squamous cell carcinoma (SCC) of the oropharynx, hypopharynx and larynx, planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. Study participants will have two PET/MRI scans, with the radiotherapy immobilization devices in situ. The first will be done prior to the start of radiotherapy, the second half way through treatment.

Image quality will be assessed by comparing to standard diagnostic scans and different registration methods will be compared to establish the best way of incorporating PET/MR image data into the radiotherapy planning system. Patient tolerability and workflow considerations will also be qualitatively assessed. Furthermore, a planning study will be conducted to establish relevant treatment protocols for a subsequent dose escalation trial.

PET/MRI is an exciting new technology with a lot of potential in the context of adaptive radiotherapy dose escalation. Within this pilot study the investigators aim to address the technical challenges of using it in this context prior to proceeding to a randomized trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications

NCT06032663

Head and Neck Cancer

RECRUITING NA

MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer

NCT02273778

Head and Neck Cancer

COMPLETED NA

PET Scans and CT Scans in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

NCT00388024

Carcinoma of Unknown Primary Head and Neck Cancer

COMPLETED

PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

NCT00809016

Head and Neck Cancer

COMPLETED NA

Measurement of Head and Neck Tumor Hypoxia With PET-MRI

NCT05246475

Head and Neck Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm imaging study

Single arm study: all patients have 2 PET/MR scans in the radiotherapy treatment position

Group Type OTHER

Imaging

Intervention Type OTHER

Single arm Imaging (PET/MR) study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imaging

Single arm Imaging (PET/MR) study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written, voluntary, informed consent
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Life expectancy \> 12 months
* Histologically proven SCC of the oropharynx, hypopharynx and larynx
* Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
* Visible disease (\>1cm) at the primary site on any imaging modality performed within 4 weeks of starting radiotherapy treatment
* Staging PET/CT and diagnostic MRI of the head and neck images need to be available for comparison.
* Adequate organ function and absence of other major concurrent illness, allowing the patient to tolerate scanning regime

Exclusion Criteria

* Inability to provide informed consent
* Impaired renal function (serum creatinine of \> 200)
* Severely impaired liver function
* Patients with allergies or contra-indications to the radio-tracer and/or contrast agent used in the study
* Severe claustrophobia or inability to tolerate PET or MRI scans
* General contra-indications to MRI, as defined in MRI safety departmental protocols
* Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
* Any patient who has urinary or faecal incontinence
* ECOG Performance Status ≥ 3
* Pregnant or breastfeeding women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No