Dose-Effect Relation of Salivary Gland Irradiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-21

Study Completion Date

2021-07-15

Brief Summary

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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.

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Detailed Description

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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

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HNSCC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RT with curative intent for HNSCC

several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks

PSMA PET/CT-scan

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No