Clinical trial NCT03367780: Dose-Effect Relation of Salivary Gland Irradiation
Official title: Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HNSCC
Keywords: Head-neck tumours
Radiotherapy
Salivary gland toxicity
PSMA PET/CT
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven mucosal squamous cell carcinoma in the head-neck area who are referred for high dose EBRT based on current clinical criteria. AVL currently treats multiple new patients per week, and with an inclusion rate of 50% this observational study can complete inclusion well within one year. The study will close after 6 months of follow-up of the last included patient, for an expected total study duration of 1.5 years.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: ΔSUV
timeFrame: 1 month
measure: the clinical evaluation of a dry mouth
timeFrame: before treatment, once during 7 weeks of treatment and follow up 6 months after
measure: the clinical evaluation of a dry mouth
timeFrame: before treatment, once a week during 7 weeks of treatment and follow up 6 months after
measure: voxel-based ΔSUV
timeFrame: 7 weeks of treatment, follow-up 1 and 6 months
measure: Voxel-based received radiation dose
timeFrame: 7 weeks of treatment, 1 and 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL)
state: Noord-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: The Netherlands Cancer Institute
name: Wouter V Vogel, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: