Dose-Effect Relation of Salivary Gland Irradiation

NCT03367780 | Completed

• 1 other identifier: N17DSI
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

HNSCC

Keywords

Head-neck tumours; Radiotherapy; Salivary gland toxicity; PSMA PET/CT

Outcome Measures

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).

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

  6 months

Secondary Outcomes (5)

• ΔSUV

  1 month

• the clinical evaluation of a dry mouth

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

• the clinical evaluation of a dry mouth

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

• voxel-based ΔSUV

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

• Voxel-based received radiation dose

  7 weeks of treatment, 1 and 6 months

Study Arms (1)

RT with curative intent for HNSCC

several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks

Device: PSMA PET/CT-scan

Interventions

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.

RT with curative intent for HNSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HNSCC of the head-neck area, cTx-4 N0-3 M0
• Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.

You may not qualify if:

• Age \<18y
• Pregnancy or lactation
• Participation in conflicting studies, e.g. with non-standard treatment and/or imaging
• Inability to provide informed consent

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (3)

The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL)

Amsterdam, North Holland, 1066CX, Netherlands

Location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Wouter V Vogel, MD,PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 11, 2017
• Study Start: November 21, 2017
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)