RECRUITING

3D Specimen Maps for RT Planning

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Virtual Patient-specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning

Quick Facts

Study Start:2023-01-26
Study Completion:2024-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05743569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:28 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Over the age of 18
  2. 2. Biopsy-confirmed mucosal head and neck cancer. All histologic malignancies will be included.
  3. 3. Patients who have completed primary tumor surgical resection in the following anatomic subsites:
  4. 1. oral cavity (oral tongue, floor of mouth, hard palate, buccal mucosa, retromolar trigone, maxillary and mandibular alveolus, lip)
  5. 2. oropharynx (soft palate, base of tongue, palatine tonsils)
  6. 3. hypopharynx (piriform sinus, post-cricoid, posterior pharyngeal wall)
  7. 4. larynx (supraglottic, glottic, subglottic);
  8. 4. Patients who have consented to 3D specimen mapping on protocol IRB # 221597 and for whom 3D specimen maps are therefore available.
  9. 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
  1. 1. Under the age of 18
  2. 2. Cutaneous malignancies
  3. 3. Characteristics that make the process of informed consent questionable
  4. 4. Pregnant women
  5. 5. Patients with contraindications to radiotherapy

Contacts and Locations

Study Contact

Marina Aweeda, BS
CONTACT
7186969882
marina.aweeda@vumc.org
Michael C Topf, MD
CONTACT
michael.topf@vumc.org

Study Locations (Sites)

Vanderbilt Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-26
Study Completion Date2024-12-26

Study Record Updates

Study Start Date2023-01-26
Study Completion Date2024-12-26

Terms related to this study

Additional Relevant MeSH Terms

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