High-Resolution PET-CT Imaging for Cancer

Overseen By Nicole Jones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt-Ingram Cancer Center

Disqualifiers: Pregnancy, Breast-feeding, High glucose, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on imaging and surgery, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment Intra-op PET/CT Specimen Scanner?

The combined PET/CT imaging technology, which the Intra-op PET/CT Specimen Scanner is based on, has been shown to improve the diagnosis, staging, and treatment monitoring of cancer by providing both anatomical and functional information in a single exam. This integration helps in better localization of cancerous lesions and guides treatment planning, making it a valuable tool in oncology. ^{1 2 3 4 5}

Is High-Resolution PET-CT Imaging for Cancer safe for humans?

Intraoperative CT imaging, which is similar to PET-CT imaging, has been used safely in surgeries, helping doctors see inside the body during operations without moving the patient. This technology has been shown to improve safety for both patients and surgeons. ^{6 7 8 9 10}

How does high-resolution PET-CT imaging differ from other cancer treatments?

High-resolution PET-CT imaging is unique because it combines detailed anatomical and molecular imaging in a single, non-invasive scan, allowing for precise localization and characterization of cancer. This integrated approach improves diagnostic accuracy and efficiency compared to traditional imaging methods, which often require separate scans and complex software registration. ^{1 2 11 12 13}

What is the purpose of this trial?

Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol. Potential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins. Time Commitment: There are no additional visits that will be asked of you to partake in this study. Drug is FDA approved and Exposure to Radiation is minimal.

Research Team

Michael Topf, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Eligibility Criteria

This trial is for individuals with uterine tumors or other forms of cancer who are undergoing surgery. The main requirement is that they're eligible for surgical tumor removal as per standard care. There's no specific exclusion criteria provided, but participants should be able to undergo the imaging process.

Inclusion Criteria

My cancer diagnosis was confirmed by a biopsy.

Have life expectancy of more than 12 weeks

Have acceptable glucose status (<200 mg/dL) at Day of Surgery prior to 18F-FDG injection

Exclusion Criteria

I cannot undergo surgery due to health reasons.

Blood glucose level over 200 mg/dL prior to 18F-FDG infusion

Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

Pre-Surgery Preparation

Patients are injected with a PET (18F-FDG) tracer to highlight cancerous tissues

Day of Surgery

Intraoperative Imaging

Once the tumor is removed, the specimen is scanned using the XEOS Aura 10 device in the operating room

Day of Surgery

Immediate Analysis

The imaging provides real-time feedback on the tumor's characteristics, such as margins and whether all cancerous tissue has been removed

Day of Surgery

Comparison with Pathology

The PET-CT images are later compared with traditional pathology results to validate their accuracy and usefulness

Day of Surgery to Pathology

Follow-up

Participants are monitored for any adverse effects and the correlation of imaging results with pathology

10 days

Treatment Details

Interventions

• Intra-op PET/CT Specimen Scanner

Trial Overview The study tests a new intraoperative PET/CT scanner designed to help surgeons see cancer margins during surgery. It aims to improve accuracy in removing tumors by providing high-resolution images without altering the standard surgical procedure.

Participant Groups

Group I: 18F-FDG Experimental Treatment 1 Intervention

After confirming inclusion/exclusion criteria, all participants will receive a one-time IV infusion of 18 F-FDG dose prior to surgical extirpation of tumor. Administration of 18 F-FDG will be injected as a bolus during surgery. Appropriate medical resources for the treatment of severe infusion reactions should be available during infusions, although these are not expected. Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Findings from Research

PET-CT imaging significantly enhances the diagnosis, staging, and monitoring of cancer treatment, providing a powerful combination of functional and anatomical information.

The use of integrated PET-CT improves the characterization of unclear lesions and reduces variability in interpretations, which can directly influence treatment planning and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated PET-CT: evidence-based review of oncology indications. Sachelarie, I., Kerr, K., Ghesani, M., et al.[2016]

Positron emission tomography (PET) using fluorine 18 fluorodeoxyglucose (FDG) is a valuable tool for diagnosing and staging cancer, as it provides functional imaging that complements traditional anatomical imaging techniques like computed tomography (CT).

The introduction of combined PET/CT scanners allows for simultaneous acquisition of anatomical and functional images, improving the accuracy of cancer diagnosis and treatment monitoring, with over 800 such scanners currently in use worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT: form and function. Blodgett, TM., Meltzer, CC., Townsend, DW.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

First Live-Experience Session with PET/CT Specimen Imager: A Pilot Analysis in Prostate Cancer and Neuroendocrine Tumor. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Towards truly integrated hardware fusion with PET/CT. [2007]

3. Scotland pubmed.ncbi.nlm.nih.gov

Case report: fusion of positron emission tomography (PET) and computed tomography (CT) images for image-guided endoscopic navigation in maxillofacial surgery: clinical application of a new technique. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Integrated PET-CT: evidence-based review of oncology indications. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

PET/CT: form and function. [2022]

6. Austria pubmed.ncbi.nlm.nih.gov

Development of the operating computerized tomographic scanner system for neurosurgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A Marker-Less Registration Approach for Mixed Reality-Aided Maxillofacial Surgery: a Pilot Evaluation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Endoscopic sinus surgery using intraoperative computed tomography imaging for updating a three-dimensional navigation system. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Accuracy of frame-based stereotactic magnetic resonance imaging vs frame-based stereotactic head computed tomography fused with recent magnetic resonance imaging for postimplantation deep brain stimulator lead localization. [2011]

10. Turkey pubmed.ncbi.nlm.nih.gov

The usefulness of intraoperative mobile computed tomography in severe head trauma. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Initial characterization of a dedicated breast PET/CT scanner during human imaging. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Focus on time-of-flight PET: the benefits of improved time resolution. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Positron emission tomography/computed tomography. [2016]