Head and Neck CancerNCT05743569
3D Specimen Maps for RT Planning
An observational study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Radiation Therapy
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- Under the age of 18
- Cutaneous malignancies
- Characteristics that make the process of informed consent questionable
- Pregnant women
- Patients with contraindications to radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Virtual Patient-specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning
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.
Read the detailed description
It is estimated that 65,000 new cases of head and neck squamous cell carcinoma (HNSCC) were diagnosed in the United States in 2020. The incidence of HNSCC is projected to increase 30% worldwide by 2030. Surgical resection is the preferred treatment for oral cavity cancer and frequently plays a role in the management of oropharyngeal and laryngeal cancer. Approximately 70-80% of patients who undergo primary resection for oropharyngeal HNSCC will receive post-operative radiotherapy. Post-operative radiotherapy is generally indicated for HNSCC with features associated with high risk of locoregional recurrence, such as stage pT3 or pT4 primary tumors, close or positive margins, multiple involved lymph nodes, extranodal extension, or the presence of multiple additional high risk features such as lymphovascular invasion, perineural invasion, deep depth of invasion, or high grade.
The delineation of post-operative target volumes for localization and radiation planning can be difficult for the treating radiation oncologist due to post-operative anatomy changes from surgical manipulation of tissues, loss of normal tissue planes, and post-operative fluid collections. Post-operative radiotherapy treatment plans and volumes are usually delineated by the radiation oncologist based on review of a combination of data points including operative reports, pre-operative and post-operative diagnostic images, pathology reports, identification of surgical clips, and discussions with the treating head and neck surgeon and/or pathologists. Generally, the post-operative Clinical Target Volume for the primary tumor (CTVp) should include the primary tumor operative bed with a suitable margin to account for microscopic spread and is generally treated to 60Gy. For tumors with a positive margin, some radiation oncologists may choose to boost the area of positive margin up to 66Gy. The CTV boost (CTVb) can be difficult to visualize, and accurate understanding of the location of the positive margin can influence how small or large the boost volume is and thus dose to adjacent normal tissues, or organs at risk (OARs).
Optical 3D scanning technology has been a standard procedure quality control in industrial manufacturing for years. Due to its speed, accuracy, and relative ease of use, 3D scanning has steadily proven its utility in medicine over the past decade. The investigators have developed a protocol for optical 3D scanning of the specimen to improve communication between the OR and pathology lab (Figure 2). The resected specimen is scanned using a structured light 3D scanner. Graphics software is then used to virtually ink and annotate 3D specimen models, indicating and clearly defining the specific anatomic locations of the frozen section margins (Figure 3). In the present study, the investigators aim to use the patient-specific 3D specimen maps to improve communication between surgeons and radiation oncologists for adjuvant radiation therapy treatment planning and determine the impact of these 3D specimen maps on CTVs and OARs.
3D innovations are numerous and have become a well-established avenue of research in otolaryngology and a variety of other fields over the past decade. Optical innovations increasingly represent a new diagnostic modality that has demonstrated potential for intraoperative guidance.The team of investigators has previously published a study on the use of 3D scanning technology and virtual graphics software to bridge the gap between the operating room and pathology lab. The investigators determined this relatively simple, non-invasive technique to be a valuable communication tool for surgeons and pathologists responsible for the care of patients with head and neck cancer. However, the utilization of this technology in post-operative discussions and treatment planning with radiation oncologists has yet to be evaluated. The overarching goal of this research is to improve communication and mutual comprehension between the surgeon, pathologist, and radiation oncologist using commercially available, readily implementable 3D scanning technology and virtual graphics software thus to improve delineation of post-operative radiation therapy target volumes for patients with head and neck cancer.
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.
Aim #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.
Aim #2 - Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist.
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).
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start26 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Topf, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743569
- Sponsor's protocol ID
- 222115
- Status last verified
- May 2026
- First submitted
- 14 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Patient-specific 3D Specimen Maps for Adjuvant Head & Neck Radiotherapy Planning
- ClinicalTrials.gov ID
- NCT05743569
- Acronym / sponsor ID
- 222115
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is estimated that 65,000 new cases of head and neck squamous cell carcinoma (HNSCC) were diagnosed in the United States in 2020. The incidence of HNSCC is projected to increase 30% worldwide by 2030. Surgical resection is the preferred treatment for oral cavity cancer and frequently plays a role in the management of oropharyngeal and laryngeal cancer. Approximately 70-80% of patients who undergo primary resection for oropharyngeal HNSCC will receive post-operative radiotherapy. Post-operative radiotherapy is generally indicated for HNSCC with features associated with high risk of locoregional recurrence, such as stage pT3 or pT4 primary tumors, close or positive margins, multiple involved lymph nodes, extranodal extension, or the presence of multiple additional high risk features such as lymphovascular invasion, perineural invasion, deep depth of invasion, or high grade.
The delineation of post-operative target volumes for localization and radiation planning can be difficult for the treating radiation oncologist due to post-operative anatomy changes from surgical manipulation of tissues, loss of normal tissue planes, and post-operative fluid collections. Post-operative radiotherapy treatment plans and volumes are usually delineated by the radiation oncologist based on review of a combination of data points including operative reports, pre-operative and post-operative diagnostic images, pathology reports, identification of surgical clips, and discussions with the treating head and neck surgeon and/or pathologists. Generally, the post-operative Clinical Target Volume for the primary tumor (CTVp) should include the primary tumor operative bed with a suitable margin to account for microscopic spread and is generally treated to 60Gy. For tumors with a positive margin, some radiation oncologists may choose to boost the area of positive margin up to 66Gy. The CTV boost (CTVb) can be difficult to visualize, and accurate understanding of the location of the positive margin can influence how small or large the boost volume is and thus dose to adjacent normal tissues, or organs at risk (OARs).
Optical 3D scanning technology has been a standard procedure quality control in industrial manufacturing for years. Due to its speed, accuracy, and relative ease of use, 3D scanning has steadily proven its utility in medicine over the past decade. The investigators have developed a protocol for optical 3D scanning of the specimen to improve communication between the OR and pathology lab (Figure 2). The resected specimen is scanned using a structured light 3D scanner. Graphics software is then used to virtually ink and annotate 3D specimen models, indicating and clearly defining the specific anatomic locations of the frozen section margins (Figure 3). In the present study, the investigators aim to use the patient-specific 3D specimen maps to improve communication between surgeons and radiation oncologists for adjuvant radiation therapy treatment planning and determine the impact of these 3D specimen maps on CTVs and OARs.
3D innovations are numerous and have become a well-established avenue of research in otolaryngology and a variety of other fields over the past decade. Optical innovations increasingly represent a new diagnostic modality that has demonstrated potential for intraoperative guidance.The team of investigators has previously published a study on the use of 3D scanning technology and virtual graphics software to bridge the gap between the operating room and pathology lab. The investigators determined this relatively simple, non-invasive technique to be a valuable communication tool for surgeons and pathologists responsible for the care of patients with head and neck cancer. However, the utilization of this technology in post-operative discussions and treatment planning with radiation oncologists has yet to be evaluated. The overarching goal of this research is to improve communication and mutual comprehension between the surgeon, pathologist, and radiation oncologist using commercially available, readily implementable 3D scanning technology and virtual graphics software thus to improve delineation of post-operative radiation therapy target volumes for patients with head and neck cancer.
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.
Aim #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.
Aim #2 - Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- Under the age of 18
- Cutaneous malignancies
- Characteristics that make the process of informed consent questionable
- Pregnant women
- Patients with contraindications to radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment fields
Time frame: 1 year
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 secondary outcome
Investigate the subjective benefit of 3D specimen mapping on postoperative communication with the radiation oncologist.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the impact of patient-specific 3D specimen maps on adjuvant radiation treatment fields (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.