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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49750

Enrollment

Registered

2020-01-09

Start date

2017-11-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry mouth (after radiotherapy) Xerostomia

Interventions

Head-neck tumours

PSMA PET/CT

Radiotherapy

Salivary gland toxicity

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main parameters are the mean radiation dose to salivary glands (Dmean), and the (relative changes in) total uptake of PSMA in salivary glands (*SUVtotal) measured at 6 months.	—

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)