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Dose‐Effect Relation of Salivary Gland Irradiation

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ClinicalTrials.gov Identifier: NCT03367780
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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.

Condition or disease Intervention/treatment
HNSCC Device: PSMA PET/CT-scan

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
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Dose‐Effect Relation of Salivary Gland Irradiation and Cell Loss With PSMA PET
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

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
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.




Primary Outcome Measures :
  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). [ Time Frame: 6 months ]
    Dmean and ΔSUVtotal‐6 are correlated to determine the dose‐effect relation.


Secondary Outcome Measures :
  1. ΔSUV [ Time Frame: 1 month ]
  2. the clinical evaluation of a dry mouth [ Time Frame: before treatment, once during 7 weeks of treatment and follow up 6 months after ]
    according to the C30+HN35 QoL

  3. 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 ]
    Groningen questionnaires

  4. voxel-based ΔSUV [ Time Frame: 7 weeks of treatment, follow-up 1 and 6 months ]
  5. Voxel-based received radiation dose [ Time Frame: 7 weeks of treatment, 1 and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367780


Contacts
Contact: Wouter V Vogel, MD, PhD +31205122267 w.vogel@nki.nl
Contact: Emilia Owers, MD +31 20 512 7917 e.owers@nki.nl

Locations
Netherlands
The Netherlands Cancer Institute- Antoni van Leeuwenhoek (NKI-AVL) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066CX
Contact: W.V. Vogel, MD,PhD    +31 20 512 2267    w.vogel@nki.nl   
Contact: E. Owers, MD    +31 20 512 7917    e.owers@nki.nl   
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands, 9700RB
Contact: Roel J.H.M. Steenbakkers, MD, PhD    +31 50 3619382    r.steenbakkers@umcg.nl   
Contact: Anneke de Haan, MD    +31 50 3610473    a.de.haan01@umcg.nl   
University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands, 3584CX
Contact: Bart de Keizer, MD,PhD    +316 24873273    b.dekeizer@umcutrecht.nl   
Contact: Tjitske Kent-Bosma       tbosma@umcutrecht.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
Principal Investigator: Wouter V Vogel, MD,PhD The Netherlands Cancer Institute

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03367780     History of Changes
Other Study ID Numbers: N17DSI
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Netherlands Cancer Institute:
Head-neck tumours
Radiotherapy
Salivary gland toxicity
PSMA PET/CT