Trials / Completed
CompletedNCT03367780
Dose-Effect Relation of Salivary Gland Irradiation
Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 32 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PSMA 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. |
Timeline
- Start date
- 2017-11-21
- Primary completion
- 2021-07-15
- Completion
- 2021-07-15
- First posted
- 2017-12-11
- Last updated
- 2021-08-19
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03367780. Inclusion in this directory is not an endorsement.