Head and Neck Cancer Clinical Trial
Official title:
Improved Implant for Reconstruction Purposes After Mandibular Resection
Study design: A single center non-randomized, prospective clinical feasibility study. Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction. Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant. Objective: The aim is to provide enough evidence through model analysis, physical tests and clinical study of 10 patients that our new type of personalized mandibular implant is safe to use, resulting in significantly fewer complications and can be practically placed during the surgery, without any complications. Main study parameters/endpoints: The study endpoint is to use the RifRaM without any implant related complications and a perfect mandibular fit.
The preoperative bony resection planning and the design of the RifRam implant will be carried out on 3D reconstructed CT image of the mandible. The necessary resection planes will be marked on the 3D model. This segment will be removed virtually and replaced by the designed RifRam implant. The form of the implant will follow the contours of the native healthy mandible. In case, extensive bone destruction of the mandible does not allow copying the contours, contralateral side of the mandible will be virtually mirrored and used to design the implant. The design of the implant will be carried out within the NKI/AVL and the data will be preserved in restricted access folders. The designed implant will be printed with a hollow mesh core by Mobius. A matching cutting guide will be printed as well. Two copies of the implant will be delivered in case one would be accidentally be unsterile (see 5.3). The cutting guides are used to cut the mandible at exactly the intended places. The implant and the cutting guide will be delivered to the hospital and sterilized by Clinium for clinical use. The patient will undergo a COMMANDO (combined mandibulectomy and neck dissection) procedure. The steps of this procedure are well defined and can be found in iProva. The oncological resection will be carried out in the standard fashion. Mandible saw cutting guides are used as standard procedure. The patient specific mandible cutting guide will be fixed on the mandible and the cuts to the mandible will be made through the cutting slots. This step enables that the mandible defect matches exactly the RifRam implant. After the resection is completed and the surgical site irrigated as per standard procedure, the Rifram implant will be placed to fill the bone defect. The implant will be fixed with 2.7 mm locking screws produced by KLS Martin. These screws are used are used as standard and are available in stock in the operation complex. The soft tissue defect will be reconstructed using a regional flap such as pectoralis major musculocutaneous flap. The rest of the procedure will be completed as per established clinical protocol. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
| Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
| Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
| Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
| Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
| Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
| Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
| Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
| Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
| Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |