200 Participants Needed

Ultrasound Imaging for Oral Cancer

(SURGIO Trial)

Recruiting at 6 trial locations
DJ
Overseen ByDaniel J Lauritzen, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tobias Todsen
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I am scheduled for surgery for early-stage mouth cancer.

Exclusion Criteria

Tumor not visible on ultrasound.
Unable to understand verbal or written information
I am under 18 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery for oral cancer, with the intervention group receiving ultrasound-guided resection

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of surgical margins, quality of life, and recurrence

24 months
Follow-up at 3 months and 12 months

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tobias Todsen

Lead Sponsor

Trials
1
Recruited
90+

Aarhus University Hospital

Collaborator

Trials
847
Recruited
6,900,000+

Karolinska Institutet

Collaborator

Trials
1,510
Recruited
32,450,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

University of Cape Town

Collaborator

Trials
257
Recruited
458,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

National Cancer Institute, Milan

Collaborator

Trials
2
Recruited
320+

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.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39406014/
Surgeon-performed intraoperative transoral ultrasound ...Intraoperative transoral US during panendoscopy is a promising diagnostic tool that may improve the detection of HPV-positive SCCUP.
Role 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 ...
Intraoperative 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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