3D Specimen Maps for RT Planning

NCT05743569 | Active Not Recruiting

• 1 other identifier: 222115
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment fields

  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.

  1 year

Secondary Outcomes (1)

• Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist.

  1 year

Eligibility Criteria

• Age: 28 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators aim to recruit adult patients with biopsy-confirmed mucosal head and neck cancer who have completed primary tumor surgical resection of their cancer.

You may qualify if:

• Over the age of 18
• Biopsy-confirmed mucosal head and neck cancer. All histologic malignancies will be included.
• Patients who have completed primary tumor surgical resection in the following anatomic subsites:
• oral cavity (oral tongue, floor of mouth, hard palate, buccal mucosa, retromolar trigone, maxillary and mandibular alveolus, lip)
• oropharynx (soft palate, base of tongue, palatine tonsils)
• hypopharynx (piriform sinus, post-cricoid, posterior pharyngeal wall)
• larynx (supraglottic, glottic, subglottic);
• Patients who have consented to 3D specimen mapping on protocol IRB # 221597 and for whom 3D specimen maps are therefore available.
• 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

You may not qualify if:

• Under the age of 18
• Cutaneous malignancies
• Characteristics that make the process of informed consent questionable
• Pregnant women
• Patients with contraindications to radiotherapy

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: January 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2025-04

Locations

US (1)