Determining the dose-effect relation of salivary gland irradiation and functional cell loss with PSMA PET<br>

Completed

• Conditions: dry mouth (after radiotherapy); Xerostomia; 10027655

• Registration Number: NL-OMON49750
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- HNSCC of the head-neck area, cTx-4 N0-3 M0
- Accepted for external beam radiotherapy in a conventionally fractionated
schedule of 6-7 weeks.
- Primary or post-operative radiotherapy
- Photon- or proton-based treatment

Exclusion Criteria

- Participation in conflicting studies, e.g. with non-standard treatment and/or
imaging (with the exception of SUSPECT-2 (CCMO protocol ID: NL68958.031.19 /
AVL-code M19SUS))
- Pregnancy or lactation
- Inability to provide informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameters are the mean radiation dose to salivary glands (Dmean), and<br /><br>the (relative changes in) total uptake of PSMA in salivary glands (*SUVtotal)<br /><br>measured at 6 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters include the (relative changes in) total uptake of PSMA in<br /><br>salivary glands (*SUVtotal) measured at baseline, during RT, and in the acute<br /><br>phase (at 1 month after RT), the voxel-based radiation dose and uptake, and<br /><br>clinical evaluation of xerostomia (EORTC QLQ C30+HN35 and Groningen<br /><br>questionnaire).</p><br>