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NCT Number: NCT06627075

Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, 35042, France

Location status: Recruiting

Location contact

Coralie Geffroy

CONTACT

[email protected]

0299253139 ext. +33

About this study

In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.

At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.

However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.

The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age
  • Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
  • Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
  • Patients who have dated and signed an informed consent form

Exclusion criteria

  • Patients with uncontrollable movements
  • Patients under psychiatric care
  • Patients who do not understand or read French
  • Patients participating in an interventional study testing another medical intervention
  • Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
  • Pregnant or breast-feeding women
  • Patients without social security coverage

Treatment and study plan

Surface Guided RadioTherapy (SGRT) without mask

Procedure

Firstly, patients are positioned in a vacuum mattress that moulds their head, neck and shoulders for a reference scan.

During the treatment sessions, patients are positioned according to the reference scan, using the surface camera system.

Once the observed offsets have been applied, the patient's surface is captured. Treatment can then begin, with continuous monitoring of displacements by the surface camera system. Automatic beam interruption is provided during treatment in the event of motion detection exceeding the standard tolerance threshold (>3 mm).

If the use of a thermoformed mask during your treatment prove necessary, for whatever reason, will not result in a halt to the research.

Patients receive between 10 and a max of 35 radiotherapy sessions. The follow-up period begins after the last radiotherapy session, and patients are assessed at 4 or 6 weeks and at 3 months by a radiotherapist.

Primary outcomes

  1. Measurement patient displacement during surface-guided radiotherapy sessions

    Time frame: Through study completion, an average of 1 year

    Average length of linear translation vector during session (measured by surface cameras) over all sessions performed

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Trochet

CONTACT

[email protected]

02 99 25 31 65 ext. +33

Valérie Jolaine

CONTACT

[email protected]

02 99 25 30 36 ext. +33

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer

Acronym: SUGAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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