Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy

NCT06726512 | Not Yet Recruiting

• 1 other identifier: NL86142.042.24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.

Conditions

Oral Cancer; Osteosarcoma; Soft Tissue Sarcoma; Oral Squamous Cell Carcinoma (OSCC)

Keywords

margin assessment; image-guided surgery; PET-CT

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is to determine the margin detection rates of a novel high-resolution mobile PET-CT for intraoperative margin assessment in OSCC, STS, and OS surgery.

  Tumor positive and negative margin detection rates of the novel high-resolution mobile PET-CT scanner compared to standard of care pathology.

  Postoperatively i.e. 7-10 working days

Study Arms (1)

2 MBq 18F-FDG

OTHER

Subjects are intravenously administered with 2.0 MBq/kg 18F-FDG, standard tracer used to diagnose and stage the malignancy. After standard of care excision of the primary tumor, a high-resolution PET-CT imaging of the fresh surgical specimen will be performed.

Device: XEOS AURA 10

Interventions

XEOS AURA 10 DEVICE

Surgery is performed according to standard of care. Directly after surgery, the surgical specimen is taken outside the operation theatre in a dedicated imaging room at the Department of Nuclear Medicine where high-resolution PET-CT imaging of the surgical specimen is performed.

Also known as: PET, PET/CT, High resolution PET/CT, Margin detection, Margin status

2 MBq 18F-FDG

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.
• Patient is indicated to undergo curative surgery of the primary tumor.
• Patient is estimated compliant for study participation by the investigator.
• Written informed consent.

You may not qualify if:

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
• Patient has previously received radiotherapy of the primary tumor region;
• Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;
• A blood glucose level over 200 mg/dL on the day of surgery.
• Pregnancy or lactation.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Mouth Neoplasms; Osteosarcoma; Sarcoma; Squamous Cell Carcinoma of Head and Neck

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Jasper Vonk, Dr.

CONTACT

+31 50 36162029; j.vonk@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: It will be available after the end date of the study. It will be available for 15 years after the study has ended.
• Access Criteria: PI and other researchers on request. They are able to access the Study Protocol and the Clinical Study Report

Locations

NL (1)