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Completed

NCT Number: NCT03367780

Dose-Effect Relation of Salivary Gland Irradiation

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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Key information

Conditions

HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSMA PET/CT-scan

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.

Primary outcomes

  1. 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).

    Time frame: 6 months

    Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation.

Secondary outcomes

  1. ΔSUV

    Time frame: 1 month

  2. the clinical evaluation of a dry mouth

    Time frame: before treatment, once during 7 weeks of treatment and follow up 6 months after

    according to the C30+HN35 QoL

  3. the clinical evaluation of a dry mouth

    Time frame: before treatment, once a week during 7 weeks of treatment and follow up 6 months after

    Groningen questionnaires

  4. voxel-based ΔSUV

    Time frame: 7 weeks of treatment, follow-up 1 and 6 months

  5. Voxel-based received radiation dose

    Time frame: 7 weeks of treatment, 1 and 6 months

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2017
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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