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GPS for surgeons: new navigation tool aims to improve head and neck cancer outcomes

NCT ID NCT05671458

Disease control Sponsor: Juergen Debus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a navigation system that helps surgeons remove head and neck tumors more precisely. During surgery, the system creates a 3D map of the tumor and its edges, which is then used to plan follow-up radiation therapy. The goal is to reduce the chance of leftover cancer cells and improve local control. The trial will enroll 60 patients with midface or skull-base tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intraoperative navigation and tumor resection maps
What this could lead to
If successful, this could make head and neck cancer surgery more precise, reducing the chance of leftover tumor and improving radiotherapy planning.
What could go wrong
This is a small early-phase trial with only 60 participants, so results may not apply to everyone. The technique is new and its benefit over standard surgery is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of a malignancy (squamous cell carcinoma (SCC), adenocarcinoma (AC), mucoepidermoid carcinoma (MEC), adenoidcystic carcinoma (ACC)) of the midface, upper jaw and skull-base (e.g. based on imaging-studies and/or biopsies) * Indication of surgical tumor resection according to multidisciplinary tumor conference * Probably indication for postoperative radiotherapy (e.g. T3/4 tumor) * Medical operability and written informed consent of the patient to undergo surgical resection (as indicated clinically) * Patient age ≥ 18 years * Karnofsky performance index ≥ 60% * For women with childbearing potential: adequate contraception * Ability of subject to understand character and individual consequences of the trial * Written informed consent to participate in this trial Exclusion Criteria: * Contraindications against radiotherapy, especially pregnant or lactating women * Refusal of the patient to take part in the study * Participation in another competing clinical study or observation period of competing trials

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Conditions

The condition(s) this trial relates to.

adenoid cystic carcinoma head and neck cancer head and neck carcinoma Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Radiotherapy, University of Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

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