Clinical trial · Observational
Dose-Effect Relation of Salivary Gland Irradiation
Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET/CT-scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- RT with curative intent for HNSCC
- description
- several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks
- interventionNames
- Device: PSMA PET/CT-scan
Primary outcomes (1)
- measure
- 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).
- timeFrame
- 6 months
- description
- Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation.
Secondary outcomes (5)
- measure
- ΔSUV
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available