Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Preoperative Virtual Reality and 3D Pathologic Modeling as Treatment for Head and Neck Squamous Cell Carcinoma
This clinical trial studies the use of virtual reality technology and three dimensional surgery (3D-surgery) modeling to enhance current treatments in head and neck cancer surgery. Virtual reality 3D-surgery modeling may improve quality of surgical planning and interdisciplinary communication between surgeons and pathologists during the treatment of head and neck squamous cell cancer and ultimately increase the accuracy of planning, the quality of communication, and maximize the outcome patients with head and neck cancer experience throughout treatment.
PRIMARY OBJECTIVES: To assess the potential for preoperative virtual reality and 3D pathological modeling to reduce total number of margin events as defined in the study as the number of positive frozen margins, number of positive final margins and the number of unexpected defect driven margins. SECONDARY OBJECTIVES: To assess the impact of preoperative virtual reality and 3D pathologic modeling as treatment for head and neck squamous cell carcinoma on event free survival (EFS) at 18-36 months after resection as defined by recurrence at the primary site. TERTIARY OBJECTIVE: I. To evaluate the quality of existing interdisciplinary intraoperative communication using the proposed VR/3D-case enhancement protocols (CEPs) as an evaluating medium. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (VR/3D-CEPs + STANDARD TREATMENT): Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical computed tomography (CT) scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29 and a 3D model of true tumor is created and imported into the virtual reality environment. ARM II (STANDARD TREATMENT): Prior to surgery (day 0-13), patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29. After completion of study intervention, patients are followed for up to 36 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03317327 -
REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02892201 -
Pembrolizumab in HNSCC With Residual Disease After Radiation
|
Phase 2 | |
| Active, not recruiting |
NCT04854499 -
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT04110249 -
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
|
N/A | |
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05338905 -
Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial
|
N/A | |
| Recruiting |
NCT04045496 -
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04096638 -
Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03070366 -
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
|
Phase 2 | |
| Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
| Terminated |
NCT02488629 -
Study of SCB01A in Patient With Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01697800 -
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
|
Phase 2 | |
| Completed |
NCT01427478 -
Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck
|
Phase 3 | |
| Recruiting |
NCT05437380 -
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
|
N/A | |
| Recruiting |
NCT05065086 -
Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
|
||
| Completed |
NCT03022409 -
A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).
|
Phase 1 | |
| Recruiting |
NCT04567056 -
Specific Methylation Profiles in HNSCC
|