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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032663
• Other study ID #: STH21185
• Secondary ID: 286722
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: Dominic Nash
• Phone: 01142265208
• Email: sth.specialisedcancerresearchadministration[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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:

1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan.

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or over

2. Able to give informed written consent.

3. New diagnosis of biopsy-proven head and neck cancer.

4. WHO performance status = 2.

5. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy.

6. MRI and PET-CT staging scans for diagnosis.

Exclusion Criteria:

1. Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents.

2. Claustrophobia or other contraindications to MRI.

3. Unable to pass through a 55 cm hula hoop.

4. Female patients that are pregnant or breastfeeding.

5. Unable to understand written or spoken English.

6. Patients not undergoing radical intent radiotherapy.

7. 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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Diagnostic Test:
• PET-MRI
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.

Locations

Country	Name	City	State
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Added benefit to diagnostic investigations	Clinical reports of the PET-MRI scan will be compared to reports from staging MRI and PET-CT scans to determine if any new diagnostic information is brought to light by PET-MRI.	12 months
Primary	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.	12 months
Secondary	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)	12 months
Secondary	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.	12 months
Secondary	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.	12 months