CancerNCT06915454
High-Resolution PET-CT Imaging for Surgical Margin Visualization
A study testing Intra-op PET/CT Specimen Scanner in people with Cancer and Solid Malignant Tumors, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Malignant Tumors, SCC - Squamous Cell Carcinoma
- What is being tested?
- Intra-op PET/CT Specimen Scanner
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed diagnosis of any solid malignancy
- Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care oncologic surgery with curative intent
- Male or female patients age ≥ 18 years
- Have life expectancy of more than 12 weeks
- Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
- Have acceptable glucose status (<200 mg/dL) at Day of Surgery prior to 18F-FDG injection
Who cannot join
- General or local contraindications for resective surgery
- Women who are pregnant or breast-feeding
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Nicole Jones, 615-936-2807, nicole.l.jones@vumc.org
Kyrionna Golliday, 615-421-1585, kyrionna.m.golliday@vumc.org
About this study
Official title: High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
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.
Read the detailed description
This pilot study explores the use of high-resolution PET imaging to identify surgical margins in solid tumors after removal. It evaluates the feasibility and potential of using PET-CT to assess tumor specimens and ensures radiation safety with a low-dose 18-FDG injection (20% of the standard dose). Previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. This research aims to gather insights into its clinical usefulness across different cases
- Conditions
- Cancer, Solid Malignant Tumors, SCC - Squamous Cell Carcinoma, HNSCC, HNSCC,Larynx, Pharynx and Oral Cavity
- Being tested
- Intra-op PET/CT Specimen Scanner
- Keywords
- undergoing surgery, Xeos, PET/CT imaging, specimen scanner, cancer margins, oral cancer, mouth cancer, tongue cancer, gum cancer, scc, head and neck cancer, pharynx, hnscc
- Medical subject headings
- Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Laryngeal Diseases, Mouth Neoplasms, Tongue Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-op PET/CT Specimen ScannerDevice
Also called XEOS Aura 10
Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device. Imaging will be obtained utilizing a XEOS AURA 10 scanner in real time while in the operating room with the surgery team still present.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG | Experimental | 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. Receives: Device: Intra-op PET/CT Specimen Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
This study is an exploratory pilot study where the main goal is to gather scientific knowledge. Since no results with a certain significance need to be proven, no power analysis will be performed.
Pre-Surgery Preparation: Patients are injected with a PET (18F-FDG) tracer. This tracer highlights cancerous tissues by emitting signals detectable by PET imaging.
Intraoperative Imaging: Once the tumor is removed, the specimen is scanned using the XEOS Aura 10 device in the operating room. This allows surgeons to get detailed images of the tumor and surrounding tissues.
Immediate Analysis: The imaging provides real-time feedback on the tumor's characteristics, such as margins and whether all cancerous tissue has been removed. This can help surgeons make decisions during the operation, like whether additional tissue needs to be excised.
Comparison with Pathology: The PET-CT images are later compared with traditional pathology results to validate their accuracy and usefulness.
Measured: Day of Surgery.
Secondary outcomes (3)
Correlate the margin status based on high-resolution specimen PET-CT images with the actual margin status based on gold standard microscopic histopathological analysis;
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
Measured: Day of Surgery to Pathology
Correlate lymph node status based on high-resolution specimen PET-CT images with the actual lymph node status based on gold standard microscopic histopathological analysis
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
Measured: Day of Surgery to Pathology
Compare the visualization of the target lesion between intraoperative high-resolution specimen PET-CT imaging and pre-operative whole-body PET-CT imaging (when performed per standard of care oncologic work-up).
Researchers will compare standard of care imaging data to the XEOS Aura 10 specimen scanner data.
Measured: Day of Surgery to 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start3 Sep 2025
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, XEOS Medical
- Responsible party
- Principal investigator, Michael Topf, Vanderbilt-Ingram Cancer Center
- Investigators
- Michael Topf, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915454
- Sponsor's protocol ID
- VICCHNP24616
- Status last verified
- May 2026
- First submitted
- 27 Mar 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We plan to share the data and key findings from our pilot study, which explored the feasibility and potential of high-resolution PET imaging for assessing surgical margins in solid tumors. This information will be made available to support further research, foster collaboration, and provide insights into the clinical application of ex vivo PET-CT imaging in oncology. Our findings include promising results from studies on various tumor types, highlighting the technique's ability to visualize tumors effectively with a low-dose radiation protocol.
Publications
Radevic A, Austerlitz J, McAdoo A, Golliday K, Takahashi T, Mehrad M, Rosenberg AJ, Murphy BA, Rosenthal E, Topf MC. Visualization of Scattered Tumor Regression Following Neoadjuvant Chemoimmunotherapy With a Novel Intraoperative PET/CT Scanner. Head Neck. 2026 May 25:10.1002/hed.70333. doi: 10.1002/hed.70333. Online ahead of print.
PubMed 42185750
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06915454
- Acronym / sponsor ID
- VICCHNP24616
- Conditions
- Cancer, Solid Malignant Tumors, SCC - Squamous Cell Carcinoma, HNSCC, HNSCC,Larynx, Pharynx and Oral Cavity
- Keywords
- undergoing surgery, Xeos, PET/CT imaging, specimen scanner, cancer margins, oral cancer, mouth cancer, tongue cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, XEOS Medical
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study explores the use of high-resolution PET imaging to identify surgical margins in solid tumors after removal. It evaluates the feasibility and potential of using PET-CT to assess tumor specimens and ensures radiation safety with a low-dose 18-FDG injection (20% of the standard dose). Previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. This research aims to gather insights into its clinical usefulness across different cases
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG | Experimental | Device: Intra-op PET/CT Specimen ScannerAfter 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy confirmed diagnosis of any solid malignancy
- Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care oncologic surgery with curative intent
- Male or female patients age ≥ 18 years
- Have life expectancy of more than 12 weeks
Key exclusion criteria (4 listed)
- General or local contraindications for resective surgery
- Women who are pregnant or breast-feeding
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-op PET/CT Specimen ScannerAlso: XEOS Aura 10Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device. Imaging will be obtained utilizing a XEOS AURA 10 scanner in real time while in the operating room with the surgery team still present. | Device | 18F-FDG |
Primary outcome
The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors.
Time frame: Day of Surgery.
This study is an exploratory pilot study where the main goal is to gather scientific knowledge. Since no results with a certain significance need to be proven, no power analysis will be performed. Pre-Surgery Preparation: Patients are injected with a PET (18F-FDG) tracer. This tracer highlights cancerous tissues by emitting signals detectable by PET imaging. Intraoperative Imaging: Once the tumor is removed, the specimen is scanned using the XEOS Aura 10 device in the operating room. This allows surgeons to get detailed images of the tumor and surrounding tissues. Immediate Analysis: The imaging provides real-time feedback on the tumor's characteristics, such as margins and whether all cancerous tissue has been removed. This can help surgeons make decisions during the operation, like whether additional tissue needs to be excised. Comparison with Pathology: The PET-CT images are later compared with traditional pathology results to validate their accuracy and usefulness.
3 secondary outcomes
Correlate the margin status based on high-resolution specimen PET-CT images with the actual margin status based on gold standard microscopic histopathological analysis;
Time frame: Day of Surgery to Pathology
Correlate lymph node status based on high-resolution specimen PET-CT images with the actual lymph node status based on gold standard microscopic histopathological analysis
Time frame: Day of Surgery to Pathology
Compare the visualization of the target lesion between intraoperative high-resolution specimen PET-CT imaging and pre-operative whole-body PET-CT imaging (when performed per standard of care oncologic work-up).
Time frame: Day of Surgery to 10 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 42185750Radevic A, Austerlitz J, McAdoo A, Golliday K, Takahashi T, Mehrad M, Rosenberg AJ, Murphy BA, Rosenthal E, Topf MC. Visualization of Scattered Tumor Regression Following Neoadjuvant Chemoimmunotherapy With a Novel Intraoperative PET/CT Scanner. Head Neck. 2026 May 25:10.1002/hed.70333. doi: 10.1002/hed.70333. Online ahead of print.
- Individual participant dataSharing planned: Undecided. We plan to share the data and key findings from our pilot study, which explored the feasibility and potential of high-resolution PET imaging for assessing surgical margins in solid tumors. This information will be made available to support further research, foster collaboration, and provide insights into the clinical application of ex vivo PET-CT imaging in oncology. Our findings include promising results from studies on various tumor types, highlighting the technique's ability to visualize tumors effectively with a low-dose radiation protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Topf, MD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-op PET/CT Specimen Scanner in people with Cancer and Solid Malignant Tumors, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Jones (615-936-2807, nicole.l.jones@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will determine the feasibility of intraoperative high-resolution specimen PET-CT imaging in solid tumors. (time frame: Day of Surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06915454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.