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

Primary Purpose

Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET-MRI
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring Head, Neck, Cancer, PET MRI

Eligibility Criteria

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

Inclusion Criteria: Aged 18 years or over Able to give informed written consent. New diagnosis of biopsy-proven head and neck cancer. WHO performance status ≤ 2. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy. MRI and PET-CT staging scans for diagnosis. Exclusion Criteria: Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents. Claustrophobia or other contraindications to MRI. Unable to pass through a 55 cm hula hoop. Female patients that are pregnant or breastfeeding. Unable to understand written or spoken English. Patients not undergoing radical intent radiotherapy. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PET-MRI within 1 week of planning scan.

    Arm Description

    Patients would not normally have a PET-MRI as well as planning scan. In this experimental arm, patients will be given a PET-MRI within 1 week of the planning scan.

    Outcomes

    Primary Outcome Measures

    Completion of PET-MRI
    To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.

    Secondary Outcome Measures

    Impact of additional PET-MRI on radiotherapy planning
    The secondary objective is to obtain pilot data on assessing the impact of the additional PET-MRI scan on the precision of radiotherapy planning. This will be assessed by comparing the radiotherapy target volumes and treatment plans with and without the use of PET-MRI scan.

    Full Information

    First Posted
    September 4, 2023
    Last Updated
    September 4, 2023
    Sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06032663
    Brief Title
    Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
    Official Title
    Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust

    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
    The primary research question to be answered in this project is "Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell?" This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan. The secondary question is "Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by: Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan. Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PET-MRI within 1 week of planning scan.
    Arm Type
    Experimental
    Arm Description
    Patients would not normally have a PET-MRI as well as planning scan. In this experimental arm, patients will be given a PET-MRI within 1 week of the planning scan.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET-MRI
    Intervention Description
    Patients that participate in the current study will have an extra PET-MRI scan, which will expose them to a small amount (4 - 6 mSv) of extra radiation.
    Primary Outcome Measure Information:
    Title
    Completion of PET-MRI
    Description
    To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Impact of additional PET-MRI on radiotherapy planning
    Description
    The secondary objective is to obtain pilot data on assessing the impact of the additional PET-MRI scan on the precision of radiotherapy planning. This will be assessed by comparing the radiotherapy target volumes and treatment plans with and without the use of PET-MRI scan.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 years or over Able to give informed written consent. New diagnosis of biopsy-proven head and neck cancer. WHO performance status ≤ 2. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy. MRI and PET-CT staging scans for diagnosis. Exclusion Criteria: Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents. Claustrophobia or other contraindications to MRI. Unable to pass through a 55 cm hula hoop. Female patients that are pregnant or breastfeeding. Unable to understand written or spoken English. Patients not undergoing radical intent radiotherapy. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominic Nash
    Phone
    01142265208
    Email
    sth.specialisedcancerresearchadministration@nhs.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Satya Garikipati, MD
    Phone
    01142265208
    Email
    s.garikipati@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Satya Garikipati, MD
    Organizational Affiliation
    STH Contracted Consultant
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be available/shared outside the study

    Learn more about this trial

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

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