- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03367780
Dose-Effect Relation of Salivary Gland Irradiation
August 18, 2021 updated by: The Netherlands Cancer Institute
Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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Utrecht, Netherlands, 3584CX
- University Medical Center Utrecht
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1066CX
- The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RT with curative intent for HNSCC
several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Dmean and ΔSUVtotal-6 are correlated to determine the dose-effect relation.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ΔSUV
Time Frame: 1 month
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1 month
|
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the clinical evaluation of a dry mouth
Time Frame: before treatment, once during 7 weeks of treatment and follow up 6 months after
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according to the C30+HN35 QoL
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before treatment, once during 7 weeks of treatment and follow up 6 months after
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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
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Groningen questionnaires
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before treatment, once a week during 7 weeks of treatment and follow up 6 months after
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voxel-based ΔSUV
Time Frame: 7 weeks of treatment, follow-up 1 and 6 months
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7 weeks of treatment, follow-up 1 and 6 months
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Voxel-based received radiation dose
Time Frame: 7 weeks of treatment, 1 and 6 months
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7 weeks of treatment, 1 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wouter V Vogel, MD,PhD, The Netherlands Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2017
Primary Completion (Actual)
July 15, 2021
Study Completion (Actual)
July 15, 2021
Study Registration Dates
First Submitted
November 20, 2017
First Submitted That Met QC Criteria
December 4, 2017
First Posted (Actual)
December 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 18, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- N17DSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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