HNSCCNCT03367780
Dose-Effect Relation of Salivary Gland Irradiation
An observational study of HNSCC, run by The Netherlands Cancer Institute at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC
- What is being tested?
- PSMA PET/CT-scan
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 3 sitesNetherlands
- Study dates
- 21 Nov 2017to 15 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- HNSCC of the head-neck area, cTx-4 N0-3 M0
- Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.
Who cannot join
- Age <18y
- Pregnancy or lactation
- Participation in conflicting studies, e.g. with non-standard treatment and/or imaging
- Inability to provide informed consent
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, North Holland, 1066CX
University Medical Center Groningen
Groningen, 9700RB
University Medical Center Utrecht
Utrecht, 3584CX
About this study
Official title: 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.
Read the 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.
- Conditions
- HNSCC
- Being tested
- PSMA PET/CT-scan
- Keywords
- Head-neck tumours, Radiotherapy, Salivary gland toxicity, PSMA PET/CT
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CT-scanDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RT with curative intent for HNSCC | several schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks Receives: Device: PSMA PET/CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
ΔSUV
Measured: 1 month
the clinical evaluation of a dry mouth
according to the C30+HN35 QoL
Measured: before treatment, once during 7 weeks of treatment and follow up 6 months after
the clinical evaluation of a dry mouth
Groningen questionnaires
Measured: before treatment, once a week during 7 weeks of treatment and follow up 6 months after
voxel-based ΔSUV
Measured: 7 weeks of treatment, follow-up 1 and 6 months
Voxel-based received radiation dose
Measured: 7 weeks of treatment, 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start21 Nov 2017
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter V Vogel, MD,PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367780
- Sponsor's protocol ID
- N17DSI
- Status last verified
- Apr 2021
- First submitted
- 20 Nov 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Dose-Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
- ClinicalTrials.gov ID
- NCT03367780
- Acronym / sponsor ID
- N17DSI
- Conditions
- HNSCC
- Keywords
- Head-neck tumours, Radiotherapy, Salivary gland toxicity, PSMA PET/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT with curative intent for HNSCC | – | Device: PSMA PET/CT-scanseveral schemes for radical (chemo)radiotherapy, administered in 30-35 fractions over 6-7 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- HNSCC of the head-neck area, cTx-4 N0-3 M0
- Accepted for EBRT in a conventionally fractionated schedule of 6-7 weeks.
Key exclusion criteria (4 listed)
- Age <18y
- Pregnancy or lactation
- Participation in conflicting studies, e.g. with non-standard treatment and/or imaging
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PET/CT-scanPSMA 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. | Device | RT with curative intent for HNSCC |
Primary outcome
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.
5 secondary outcomes
ΔSUV
Time frame: 1 month
the clinical evaluation of a dry mouth
Time frame: before treatment, once during 7 weeks of treatment and follow up 6 months after
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
voxel-based ΔSUV
Time frame: 7 weeks of treatment, follow-up 1 and 6 months
Voxel-based received radiation dose
Time frame: 7 weeks of treatment, 1 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter V Vogel, MD,PhD principal investigator
The Netherlands Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HNSCC, run by The Netherlands Cancer Institute at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.