HNSCC
Conditions
Keywords
Head-neck tumours, Radiotherapy, Salivary gland toxicity, PSMA PET/CT
Brief summary
Optimization of radiotherapy to reduce xerostomia is difficult, because many gland locations cannot be seen with current imaging modalities and biological dose-effect are currently insufficiently understood. PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal. A reduction of PSMA accumulation in salivary glands is thought to correlate with loss of vital acinar cells. The PET images can be correlated with radiotherapy dose distributions in gland-based or voxel-based evaluations. This makes PSMA PET a suitable instrument to derive the radiobiological dose-effect relations that are required to develop better and gland-specific dose constraints for radiotherapy. The results of this study can contribute to lower toxicity and better quality of life in patients treated with high-dose radiotherapy in the head and neck.
Detailed description
Primary objective of this prospective observational study is to determine the gland-based dose-effect relation between conventionally fractionated radiotherapy (RT) and long-term loss of acinar cells, per salivary gland type. The study population consists of a maximum of 20 patients with HNSCC referred for high-dose (CC)RT. There is no therapeutic intervention. Diagnostic intervention is PSMA PET/CT.
Interventions
DEVICEPSMA PET/CT-scan
PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal.
Sponsors
The Netherlands Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HNSCC of the head-neck area, cTx-4 N0-3 M0 * Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.
Exclusion criteria
* Age \<18y * Pregnancy or lactation * Participation in conflicting studies, e.g. with non-standard treatment and/or imaging * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the mean received radiation dose to salivary glands (Dmean), and the total uptake of PSMA in salivary glands (SUVtotal) and its relative reduction after radiotherapy (ΔSUVtotal-6). | 6 months | Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔSUV | 1 month | — |
| the clinical evaluation of a dry mouth | before treatment, once during 7 weeks of treatment and follow up 6 months after | according to the C30+HN35 QoL |
| voxel-based ΔSUV | 7 weeks of treatment, follow-up 1 and 6 months | — |
| Voxel-based received radiation dose | 7 weeks of treatment, 1 and 6 months | — |
Countries
Netherlands
Outcome results
None listed