NCT05429099 Mandibular Reconstruction Preplanning (ViPMR)
| NCT ID | NCT05429099 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Oral Cavity Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2027-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2022-10-15 with a primary completion date of 2027-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.
Eligibility Criteria
Inclusion Criteria: * primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery * are over the age of 18 * cognitive ability and language skills that allow participation in the trial * provide informed consent Exclusion Criteria: * severe comorbidities including metastatic disease * do not have a recent (within 30 days) CT scan and are unable/unwilling to receive a head CT scan at the latest 6 days prior to surgery * prior history of head or neck cancer within last 5 years * prior history of head or neck radiation treatment at any time * pregnant of lactating women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05429099 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Cavity Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05429099 currently recruiting?
Yes, NCT05429099 is actively recruiting participants. Contact the research team at eitan.prisman@ubc.ca for enrollment information.
Where is the NCT05429099 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05429099 clinical trial?
NCT05429099 is sponsored by University of British Columbia. The trial plans to enroll 420 participants.
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