Head and Neck CancerNCT06032663
Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
A study testing PET-MRI in people with Head and Neck Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Contact Person, 44-141-201-4200
About this study
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.
- Conditions
- Head and Neck Cancer
- Being tested
- PET-MRI
- Keywords
- Head, Neck, Cancer, PET MRI
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| PET-MRI within 1 week of planning scan. | Experimental | 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. Receives: Diagnostic Test: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Impact of additional PET-MRI on radiotherapy target volumes
The secondary objective is to compare the radiotherapy target volumes between conditions (with vs without the use of PET-MRI scan)
Measured: 12 months
Impact of additional PET-MRI on treatment plan
Assess inter- and intra-observer variability in treatment contours and precision of target delineation in the three categories above (CT, CT-MRI, and CT-PET-MRI scans). This will be assessed using Hausdorff distance in the three categories.
Measured: 12 months
Impact of additional PET-MRI on treatment plan
Assess inter- and intra-observer variability in treatment contours and precision of target delineation in the three categories above (CT, CT-MRI, and CT-PET-MRI scans). This will be assessed using Dice Similarity Index in the three categories.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start2 Jan 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satya Garikipati, MD, Principal investigator, STH Contracted Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032663
- Sponsor's protocol ID
- STH21185
- Other IDs
- 286722
- Status last verified
- Apr 2024
- First submitted
- 4 Sep 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available/shared outside the study
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications
- ClinicalTrials.gov ID
- NCT06032663
- Acronym / sponsor ID
- STH21185
- Conditions
- Head and Neck Cancer
- Keywords
- Head, Neck, Cancer, PET MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-MRI within 1 week of planning scan. | Experimental | Diagnostic Test: PET-MRIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRIPatients 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. | Diagnostic test | PET-MRI within 1 week of planning scan. |
Primary outcome
Completion of PET-MRI
Time frame: 12 months
To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.
3 secondary outcomes
Impact of additional PET-MRI on radiotherapy target volumes
Time frame: 12 months
Impact of additional PET-MRI on treatment plan
Time frame: 12 months
Impact of additional PET-MRI on treatment plan
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No. IPD will not be available/shared outside the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satya Garikipati, MD principal investigator
STH Contracted Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI in people with Head and Neck Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominic Nash (01142265208, sth.specialisedcancerresearchadministration@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of PET-MRI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.