High-Resolution PET-CT Imaging for Cancer

Overseen By Kyrionna Golliday

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique to help surgeons identify the edges of cancerous tumors during surgery. The process uses a special PET/CT scanner, the Intra-op PET/CT Specimen Scanner, to take detailed images of the tumor after removal. The trial includes individuals diagnosed with any solid cancer who are scheduled for surgery. Participants receive a one-time injection of a tracer (18F-FDG) to highlight the tumor during imaging. The trial requires no extra visits and involves minimal radiation exposure. As an unphased trial, this study allows participants to contribute to innovative research that could improve surgical outcomes for future cancer patients.

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 prior data suggests that this imaging device is safe for intraoperative use?

Research has shown that 18F-FDG, the substance used in PET-CT scans, is generally safe for people. Similar to sugar, this substance is often used in cancer scans. Although slightly radioactive, the amount is very low and safe for medical use. Studies have not identified any major risks or serious side effects from its use. However, as with any medical procedure, there is a small chance of mild reactions, such as discomfort at the injection site. Overall, using 18F-FDG in scans is common and has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques for cancer, which often rely on separate PET and CT scans, the Intra-op PET/CT Specimen Scanner offers a combined, high-resolution imaging solution during surgery. This treatment uses an innovative approach by incorporating the 18F-FDG tracer, allowing for more precise imaging of tumors immediately after they are resected. Researchers are excited about this method because it could lead to more accurate assessments of cancerous tissues, potentially improving surgical outcomes and reducing the need for additional surgeries.

What evidence suggests that this PET/CT imaging device is effective for cancer?

Research has shown that 18F-FDG PET/CT scans are highly effective for detecting and managing cancer. One study found these scans to be more accurate in determining tumor stage, with an 86% accuracy rate compared to 63% for CT scans alone. This trial will use 18F-FDG PET/CT imaging, with all participants receiving a one-time IV infusion of 18F-FDG before surgical removal of the tumor. This imaging method can detect cancer that other methods might miss, leading to changes in treatment plans in about 22% of cases. It also helps predict the risk of cancer recurrence or progression. Overall, 18F-FDG PET/CT serves as a powerful tool for enhancing cancer care and treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Topf, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

XEOS Medical

Industry Sponsor

Trials

3

Recruited

210+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3101722/

18F-FDG PET/CT Imaging In Oncology - PMC - PubMed Central 18 F-FDG PET/CT is more sensitive and specific in certain cancers and has been applied primarily as a staging and restaging tool that can guide patient care.

2. ajronline.org ajronline.org/doi/10.2214/AJR.09.3731

18F-FDG PET/CT of Patients With Cancer A study [4] of the cases of 260 patients with cancer revealed that PET/CT is significantly more accurate (86%) in tumor staging than is CT alone (63%), PET ...

3. e-jyms.org e-jyms.org/journal/view.php?number=2802

Diagnostic performance of F-18 FDG PET or PET/CT for ... This meta-analysis of the data from 17 studies assessed the diagnostic performance of F-18 FDG PET and PET/CT in detecting disease recurrence

4. jnm.snmjournals.org jnm.snmjournals.org/content/65/10/1557

Evaluating the Utility of 18F-FDG PET/CT in Cancer of ... F-FDG PET/CT demonstrated a primary site detection rate of 41%, resulted in a change in management in 22%, and identified previously occult ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0001299825000145

Impact of [18F]FDG PET/CT Radiomics and Artificial ... Radiomic analysis on [18F]FDG PET/CT seems to be a promising prognostic tool for predicting survival and recurrence risk in lung cancer. For progression-free ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557653/

Fludeoxyglucose (18F) - StatPearls - NCBI Bookshelf - NIH Images from PET and CT can be viewed side by side or fused using the software. Fludeoxyglucose F18 is a radioactive drug and emits radiation. ...

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2807033

FDG PET Scans in Cancer Care | Oncology Avoid intense exercise for 2 days before the FDG PET scan. For 24 hours before the scan, avoid sugar intake and follow a low-carbohydrate diet. ...

8. radiologyinfo.org radiologyinfo.org/en/info/pet

PET/CT - Positron Emission Tomography/Computed ... The most common radiotracer is F-18 fluorodeoxyglucose (FDG), a molecule similar to glucose. Cancer cells are more metabolically active and may absorb glucose ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/47/5/885

Procedure Guideline for Tumor Imaging with 18F-FDG PET/CT ... The purpose of these guidelines is to assist physicians in recommending, performing, interpreting, and reporting the results of 18 F-FDG PET/CT for oncologic ...

10. radioprotection.org radioprotection.org/articles/radiopro/full_html/2019/02/radiopro190004/radiopro190004.html

External radiation exposure rate after 18F-FDG PET/CT ... This study aimed to measure the rate of radiation emitted from patients that underwent 18 FDG PET/CT examination for oncological conditions.