Clinical trial · Observational
3D Specimen Maps for RT Planning
Virtual Patient-specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment volumes and doses to critical organs. All patients will receive standard-of-care post-operative radiotherapy not impacted by the experimental 3D specimen maps. The secondary objective is to demonstrate the feasibility of incorporating 3D specimen mapping tools into post-operative communication, and to determine if utilization of the 3D specimen map improves post-operative communication between surgeons, pathologists, and radiation oncologists.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment fields
- timeFrame
- 1 year
- description
- The investigators hypothesize that the use of virtual 3D specimen mapping in radiation treatment planning will impact clinical target volumes (CTVs) to the primary tumor bed (CTVp) and/or boost (CTVb) and doses to adjacent organs at risk because of improved understanding of gross and microscopic tumor involvement. The investigators will compare volume measurements between CTVs of two radiation treatment plans: one using standard of care planning techniques and the other with the addition of virtual 3D specimen mapping. The investigators will also compare radiotherapy doses to determine any changes to adjacent organs at risk between the two radiation treatment plans. All patients will be treated with the standard of care radiation plan that does not incorporate the 3D specimen tool.
Secondary outcomes (1)
- measure
- Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist.
- timeFrame
- 1 year
- description
- The investigators hypothesize that 3D scanning and specimen mapping will benefit key stakeholders (surgeons, pathologists, radiation oncologists). Surveys will be administered at baseline and at the end of the study to assess the perceived effect of the 3D specimen tool on post-operative communication of pathology relevant to radiation field design (ie, location of positive or close margins, orientation of gross tumor in specimen, volume of resected specimen, etc).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 28 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available