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| ID | Type | Description | Link |
|---|---|---|---|
| 286722 | Other Identifier | IRAS |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-MRI | Diagnostic 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Impact of additional PET-MRI on treatment plan |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominic Nash | Contact | 01142265208 | sth.specialisedcancerresearchadministration@nhs.net | |
| Satya Garikipati, MD | Contact | 01142265208 | s.garikipati@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Satya Garikipati, MD | STH Contracted Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research Centre at Weston Park Hospital | Recruiting | Sheffield | England | S1O 2SJ | United Kingdom |
IPD will not be available/shared outside the study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2022 | Sep 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
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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 |
| 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 |