Ultrasound Imaging for Oral Cancer
(SURGIO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to enhance the effectiveness of oral cancer surgeries by incorporating ultrasound technology during the procedure. The goal is to enable surgeons to remove tumors with greater precision, potentially reducing the need for follow-up treatments, such as additional surgeries or radiation. Participants will be divided into two groups: one will undergo the usual surgery, while the other will have surgery with ultrasound guidance performed by the surgeon. The trial seeks individuals diagnosed with specific types of oral cancer who are scheduled for surgery. As an unphased trial, it offers a unique opportunity to contribute to advancements in surgical precision and potentially improve outcomes for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that surgeon-performed ultrasound is safe for improving surgical treatment in oral cancer?
Research has shown that ultrasound use during surgeries, when performed by surgeons, is very safe. One study found that this method helped locate tumors more accurately without harming patients. Another study confirmed its safety and suggested it might help surgeons remove tumors more effectively.
Ultrasound has primarily been used before surgery to measure the size of oral tumors and has proven accurate. By providing real-time images to guide surgery, it adds no extra risk. The technology is non-invasive, using sound waves to create pictures without entering the body.
Overall, current evidence indicates that surgeon-performed ultrasound is well-tolerated and does not cause significant side effects.12345Why are researchers excited about this trial?
Researchers are excited about using surgeon-performed ultrasound for oral cancer because it offers real-time imaging to guide the surgery. Unlike standard surgical methods that rely on visual inspection and palpation, this technique uses ultrasound to provide a clear view of the surgical margins during the procedure. This could potentially lead to more precise removal of the tumor, minimizing the chances of leaving cancerous tissue behind. The ability to visualize the resection plane as a hyperechoic border in real-time is a game-changer, as it may improve surgical outcomes and reduce the need for additional surgeries.
What evidence suggests that surgeon-performed ultrasound is effective for improving surgical outcomes in oral cancer?
This trial will compare standard surgical procedures with the use of surgeon-performed ultrasound during oral cancer surgeries. Research has shown that ultrasound during these surgeries can improve tumor removal accuracy. Studies have found that ultrasound allows doctors to see and measure tumors more clearly during surgery. This real-time imaging can lead to cleaner cancer removal, leaving less behind. Achieving clear margins can reduce the need for additional treatments like radiation. This method might also lower the risk of cancer recurrence and enhance the overall quality of life for patients.23567
Are You a Good Fit for This Trial?
This trial is for individuals with oral cancers, specifically tongue cancer and squamous cell carcinoma. Participants must be eligible for surgery. Those who have received prior treatment for their oral cancer or have conditions that interfere with ultrasound use are likely excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery for oral cancer, with the intervention group receiving ultrasound-guided resection
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of surgical margins, quality of life, and recurrence
What Are the Treatments Tested in This Trial?
Interventions
- Surgeon-performed Ultrasound
Trial Overview
The study tests if using ultrasound during surgery can help remove tumors more effectively in oral cancer patients. Half the participants will get standard treatment; the other half will also have ultrasound-guided surgery to see if it improves outcomes like clear margins and quality of life.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed.
The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tobias Todsen
Lead Sponsor
Aarhus University Hospital
Collaborator
Karolinska Institutet
Collaborator
Emory University
Collaborator
University of Cape Town
Collaborator
Stanford University
Collaborator
National Cancer Institute, Milan
Collaborator
Citations
Intraoperative Ultrasound for the Management of Oral ...
Ultrasound (US) has largely been used in preoperative evaluation to assess the extent of oral tongue tumors. Its accuracy in measuring tumor ...
Surgeon-performed intraoperative transoral ultrasound ...
In this study we found that intraoperative surgeon-performed transoral US on patients with HPV-positive SCCUP could locate the primary tumor with a higher ...
Can High-Frequency Intraoral Ultrasound Predict ...
Researchers explored the use of high-frequency intraoral ultrasonography (IOUS) to predict histological risk factors in OSCC.
Surgeon-performed intraoperative transoral ultrasound ...
Intraoperative transoral US during panendoscopy is a promising diagnostic tool that may improve the detection of HPV-positive SCCUP.
5.
journals.lww.com
journals.lww.com/jrs/fulltext/9900/role_of_intraoral_ultrasound_in_assessment_of.29.aspxRole of Intraoral Ultrasound in Assessment of Depth of...
The IOUS can be recommended as an adjunct to magnetic resonance imaging in the preoperative staging of anterior oral cavity SCC.
Surgeon-performed Ultrasound for Real-time Guidance In ...
We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using ...
7.
aao-hnsfjournals.onlinelibrary.wiley.com
aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599817742856Intraoperative Ultrasound in Oral Tongue Cancer Resection ...
Our preliminary report confirms the safety of this approach and suggests that ultrasound has the potential to improve our ability to obtain a ...
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