Using 3D maps to improve radiation therapy planning for head and neck cancer
Virtual Patient-specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning
This study is testing if using 3D maps of patients' tumors can help doctors plan better radiation therapy for people who have had surgery for head and neck cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 13 (estimated) |
| Ages | 28 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05743569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of patient-specific 3D specimen maps on the planning of post-operative radiation therapy for head and neck cancer. It will assess how these maps influence treatment volumes and doses to critical organs while patients receive standard-of-care radiotherapy. Additionally, the study seeks to determine the feasibility of integrating 3D mapping tools into post-operative communication among surgeons, pathologists, and radiation oncologists. The study will include patients who have undergone surgical resection for head and neck cancers and are indicated for curative-intent radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with biopsy-confirmed mucosal head and neck cancer who have completed primary surgical resection and are scheduled to receive post-operative radiotherapy.
Not a fit: Patients under 18 or those with cutaneous malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the precision of radiation therapy, potentially reducing side effects and improving treatment outcomes for patients with head and neck cancer.
How similar studies have performed: While the use of 3D mapping in radiation therapy is gaining traction, this specific application in post-operative head and neck cancer treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over the age of 18 2. Biopsy-confirmed mucosal head and neck cancer. All histologic malignancies will be included. 3. Patients who have completed primary tumor surgical resection in the following anatomic subsites: 1. oral cavity (oral tongue, floor of mouth, hard palate, buccal mucosa, retromolar trigone, maxillary and mandibular alveolus, lip) 2. oropharynx (soft palate, base of tongue, palatine tonsils) 3. hypopharynx (piriform sinus, post-cricoid, posterior pharyngeal wall) 4. larynx (supraglottic, glottic, subglottic); 4. Patients who have consented to 3D specimen mapping on protocol IRB # 221597 and for whom 3D specimen maps are therefore available. 5. Patients are indicated to receive curative-intent post-operative radiotherapy and intend to receive radiotherapy at Vanderbilt University Medical Center or Vanderbilt Ingram Cancer Center sites in Nashville, Franklin, or Lebanon Exclusion Criteria: 1. Under the age of 18 2. Cutaneous malignancies 3. Characteristics that make the process of informed consent questionable 4. Pregnant women 5. Patients with contraindications to radiotherapy
Where this trial is running
Nashville, Tennessee
- Vanderbilt Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Marina Aweeda, BS
- Email: marina.aweeda@vumc.org
- Phone: 7186969882
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.