Dose-Effect Relation of Salivary Gland Irradiation

HNSCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367780
• Other study ID #: N17DSI
• Status: Completed
• Start date: November 21, 2017
• Est. completion date: July 15, 2021

Study information

• Verified date: April 2021
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HNSCC

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL)	Amsterdam	Noord-Holland
Netherlands	University Medical Center Groningen	Groningen
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?SUVtotal-6).	Dmean and ?SUVtotal-6 are correlated to determine the dose-effect relation.	6 months
Secondary	?SUV		1 month
Secondary	the clinical evaluation of a dry mouth	according to the C30+HN35 QoL	before treatment, once during 7 weeks of treatment and follow up 6 months after
Secondary	the clinical evaluation of a dry mouth	Groningen questionnaires	before treatment, once a week during 7 weeks of treatment and follow up 6 months after
Secondary	voxel-based ?SUV		7 weeks of treatment, follow-up 1 and 6 months
Secondary	Voxel-based received radiation dose		7 weeks of treatment, 1 and 6 months