Surgeon-performed Intraoperative Transoral Ultrasound for Cancer of Unknown Primary

NCT05841966 | Completed

• 1 other identifier: Unknown Primary Transoral US
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Adult patients suspected of Squamous Cell Carcinoma of Unknown Primary (SCCUP) will be prospectively enrolled at a tertiary head \& neck cancer center at Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. All patients will undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computerized Tomography (PET-CT) prior to examination in general anesthesia. During general anesthesia, Intraoperative Transoral Ultrasound (ITUS) will be performed prior to panendoscopy. Detected tumors will be registered with specified oropharyngeal sub-locations. Blinded to ITUS, a consultant head \& neck surgeon will perform panendoscopy. After examination, the surgeon is unblinded to ultrasound results. Final histopathology results from location-specified biopsies performed will be used as reference standard. The overall detection rate will be compared between ITUS, panendoscopy, PET-CT and MRI with sensitivity and specificity analysis. Oropharynx sub-location specific detection rate of ITUS vs. panendoscopy will be compared with logistic regression analysis.

Conditions

Cancer of Unknown Primary Site; Unknown Primary Cancer; Unknown Primary, Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Increased detection rate by adding ITUS to panendoscopy

  The difference in proportion of patients with SCCUP where a primary tumor location is correctly detected by ITUS but not detected with panendoscopy alone.

  Within 2-4 weeks after panendoscopy.

Secondary Outcomes (2)

• Ultrasonographic features of primary tonsil and tongue base tumors

  1 year

• Comparison of detection rate of ITUS, panendoscopy, combined ITUS+panendoscopy, MRI and PET-CT for locating the primary tumor.

  1 year

Other Outcomes (1)

• Average time in minutes used to perform transoral ultrasound

  1 year

Study Arms (1)

Intraoperative Transoral Ultrasound

EXPERIMENTAL

Transoral ultrasound of the tonsils and tongue base under general anesthesia.

Diagnostic Test: Transoral Ultrasound

Interventions

Transoral Ultrasound DIAGNOSTIC_TEST

The tonsils and tongue base will be scanned transorally using high-frequency intraoperative ultrasound transducers. Direct contact with the tonsils through the mouth is achieved during general anesthesia.

Intraoperative Transoral Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytology-verified cervical lymph node metastasis from squamous cell carcinoma in neck levels I-IV with HPV+ cytology.
• Booked for panendoscopic examination under general anesthesia.
• Pre-operative MRI and PET-CT available.

You may not qualify if:

• Unable to provide written informed consent.
• Unable to complete full surgical work-up including palatine- and lingual tonsillectomy.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator

Study Sites (2)

Århus University Hospital, Department of Otorhinolaryngology, Head & Neck Surgery

Aarhus, 8200, Denmark

Location

Rigshospitalet, Department of Otorhinolaryngology, Head & Neck Surgery & Audiology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Tobias Todsen, MD, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: May 3, 2023
• Study Start: February 21, 2023
• Primary Completion: January 29, 2024
• Study Completion: March 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)