Improving surgical guidance for head and neck tumor treatment
Multiparametric Imaging-based Intraoperative Navigation for Guidance of Surgical Resection and Postoperative Radiotherapy in Patients With Head-and-neck Tumors - NAVIGATORR
This study is testing a new way to help doctors remove head and neck tumors more accurately during surgery to improve treatment for patients with certain types of cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT05671458 on ClinicalTrials.gov |
What this trial studies
This trial aims to enhance local tumor control in head-and-neck cancer by utilizing multiparametric imaging for precise surgical resection and tailored postoperative radiotherapy. It focuses on patients with squamous cell carcinomas and salivary gland carcinomas, who are undergoing surgical treatment. The approach involves intraoperative navigation and the creation of tumor resection maps to improve surgical outcomes. The study seeks to personalize treatment strategies based on individual tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of head and neck malignancies requiring surgical resection and likely needing postoperative radiotherapy.
Not a fit: Patients who are contraindicated for radiotherapy or those who refuse to participate in the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and improved control of head and neck tumors.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical precision and outcomes in oncology.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heidelberg
- Department of Radiotherapy, University of Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Sebastian Regnery, PD Dr.
- Email: sebastian.regnery@med.uni-heidelberg.de
- Phone: +49 6221 56 8202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.