 |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05743569 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : February 24, 2023 Last Update Posted : February 24, 2023 |
Sponsor:
Information provided by (Responsible Party):
Michael Topf, Vanderbilt University Medical Center
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.
| Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Radiation Therapy |
Show detailed description| Study Type : | Observational |
| Estimated Enrollment : | 13 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Virtual Patient-specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning |
| Actual Study Start Date : | January 26, 2023 |
| Estimated Primary Completion Date : | January 26, 2024 |
| Estimated Study Completion Date : | January 26, 2024 |
- Measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment fields [ Time Frame: 1 year ]
We 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.
We 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. We 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.
- Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist. [ Time Frame: 1 year ]
We 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 28 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
We aim to recruit adult patients with biopsy-confirmed mucosal head and neck cancer who have completed primary tumor surgical resection of their cancer.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under the age of 18
- Cutaneous malignancies
- Characteristics that make the process of informed consent questionable
- Pregnant women
- Patients with contraindications to radiotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05743569
| Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Kavita Prasad, BA   650-793-9621   kavita.prasad.1@vumc.org   | |
| Sub-Investigator: Natalie Lockney, MD Â Â Â Â Â Â | |
| Sub-Investigator: Dakim Gaines, MD Â Â Â Â Â Â | |
| Sub-Investigator: Kayvon Sharif, BA Â Â Â Â Â Â | |
Vanderbilt University Medical Center
| Responsible Party: | Michael Topf, Assistant Professor, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT05743569 Â Â |
| Other Study ID Numbers: | 222115 |
| First Posted: | February 24, 2023 Â Â Key Record Dates |
| Last Update Posted: | February 24, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Squamous Cell Carcinoma of Head and Neck Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
