An interventional study of Intra-op PET/CT Specimen Scanner in Cancer, Solid Malignant Tumors and SCC - Squamous Cell Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Vanderbilt-Ingram Cancer Center · Not applicable, Interventional, and Supportive care
Among 24 studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center — 9 open to participants now, 9 under way, none of them phase 3. Squamous Cell Carcinoma of Head and Neck · Vanderbilt-Ingram Cancer Center.
Among the 24 studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center, this one is the 2nd largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2025, is the only one with no phase, and was the 20th registered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →9 of the 24 studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center are open now, in 1 country. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 40 across the 13 interventional studies, 58 across the 11 observational. Of the 15 that completed or were terminated, 4 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
2 of the studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05996432Vanderbilt-Ingram Cancer CenterImage-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy | 2026-11-30 |
| NCT06915454Vanderbilt-Ingram Cancer CenterHigh-Resolution PET-CT Imaging for Surgical Margin Visualization | 2027-05 |
Add all 2 to your calendar (.ics) → With an account.
Among the 24 studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Intra-op PET/CT Specimen Scanner
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.
Also known as: XEOS Aura 10
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.
Time frame: Day of Surgery.
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.
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
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
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).
Researchers will compare standard of care imaging data to the XEOS Aura 10 specimen scanner data.
Time frame: Day of Surgery to 10 days.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Started Sep 2025 (actual). Primary completion is estimated for May 2027, 20 months after the start.
Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's planned 20 months is below that.
Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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