Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05671458

Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors - NAVIGATORR

Led by Juergen Debus · Updated on 2026-01-12

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach to improve local tumor control in patients with head and neck cancer, specifically focusing on tumors of the midface, upper jaw, and skull base. The study aims to enhance the precision of surgical tumor removal and personalize radiotherapy plans. This trial addresses the current stagnation in surgical oncology for head and neck cancers by integrating advanced imaging and navigation techniques during surgery, supported by interdisciplinary collaboration among surgeons, pathologists, and radiation oncologists. The study involves 60 patients who will undergo surgery guided by intraoperative navigation and the creation of detailed tumor resection maps. These maps accurately mark tumor margins and potential residual tumor areas and are combined with histopathological information. The 3D resection maps are then used in radiotherapy planning to tailor postoperative treatment. This multidisciplinary workflow is designed to achieve clear surgical margins and improve treatment outcomes. Participants will be closely monitored for safety within 24 months after radiotherapy, with primary focus on the safety of tumor resection. Researchers will also assess local tumor control and overall survival, comparing results to existing literature. Data exchange among the clinical teams supports personalized care. The study requires patients to consent, be medically operable, and have an expected need for postoperative radiotherapy. Total participation includes surgery and long-term follow-up assessments.

CONDITIONS

Brief Title

Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a malignancy (squamous cell carcinoma, adenocarcinoma, mucoepidermoid carcinoma, or adenoidcystic carcinoma) of the midface, upper jaw, or skull base
  • Recommended surgical tumor removal by a multidisciplinary tumor conference
  • Likely need for postoperative radiotherapy (e.g., T3/4 tumor stage)
  • Medically operable and able to give written informed consent
  • Age 18 years or older
  • Karnofsky performance index of 60% or higher
  • For women who can have children: use of adequate contraception
  • Ability to understand the trial and its consequences
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Contraindications to radiotherapy, including pregnancy or lactation
  • Refusal to participate in the study
  • Participation in another competing clinical trial or observation period of competing trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 1 week or until discharge

Participants undergo surgical tumor removal guided by intraoperative navigation, which includes creation of tumor resection maps to guide surgery and postoperative radiotherapy planning.

1 surgical visit and immediate post-operative care visits

Post-operative Follow-up

Duration - Up to 24 months after radiotherapy

Participants receive postoperative radiotherapy and are monitored for safety and local tumor control.

Regular follow-up visits during radiotherapy and for 24 months afterward

Trial Site Locations

Total: 1 location

1

Department of Radiotherapy, University of Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

S

Sebastian Regnery, PD Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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