HyperSight CBCT Imaging for Cancer

Recruiting at 2 trial locations

Overseen By Sean Davidson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varian, a Siemens Healthineers Company

Disqualifiers: ECOG ≥3, Wheelchair bound, Life expectancy <3 months, Pregnant, Vulnerable populations, 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 technology called HyperSight CBCT, which aids in radiation therapy for cancer patients. The researchers aim to determine if HyperSight provides clearer images than the usual CBCT, potentially improving the planning and delivery of radiation treatments. The trial involves patients receiving radiation therapy for cancers such as head, neck, or liver, who already use CBCT for treatment positioning. Patients undergoing radiation therapy for these cancers might find this trial suitable. As an unphased trial, participation offers a chance to contribute to innovative research that could enhance future cancer treatment planning.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on imaging technology, so it's unlikely to require changes to your medication, but you should confirm with the study team.

What prior data suggests that this imaging technology is safe?

Research has shown that HyperSight CBCT imaging is safe for people. Previous studies compared the image quality of HyperSight CBCT to regular CBCT, focusing on image enhancement rather than safety issues. However, no reports of safety problems with HyperSight CBCT have emerged.

HyperSight CBCT creates images during radiation therapy and is already integrated into some treatment machines, indicating it is well-tolerated by patients. Additionally, HyperSight imaging provides clearer images and faster scans compared to older CBCT methods, potentially making the process more comfortable for patients.

While studies have primarily focused on image quality, the integration of HyperSight into existing systems and its use with patients suggest its safety. No evidence of safety concerns exists, making it reasonable to consider HyperSight CBCT safe for use in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HyperSight CBCT Imaging because it offers a new way to visualize cancer that could enhance precision in diagnosis and treatment planning. Unlike traditional imaging methods like MRI or standard CT scans, HyperSight CBCT provides high-resolution, 3D images with potentially lower radiation exposure. This technique could lead to earlier detection of tumors and more accurate assessments of how a cancer is responding to treatment, ultimately improving patient outcomes.

What evidence suggests that HyperSight CBCT is effective for improving radiation treatment delivery?

Studies have shown that HyperSight CBCT, the investigational treatment in this trial, provides clearer images than traditional CBCT. Research indicates that its accuracy in calculating radiation doses closely matches that of standard CT scans, with a difference of less than 1%. This accuracy makes the images more reliable for planning radiation therapy. The system captures images quickly, in just six seconds, and minimizes errors that can blur the images. Overall, HyperSight CBCT offers better image contrast and less background noise, which is crucial for planning effective cancer treatment. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for cancer patients with conditions like breast, lung, genitourinary cancers, hepatocellular carcinoma, gastrointestinal cancer, and head and neck cancers. Participants should be undergoing radiation therapy and able to undergo additional CBCT imaging without health risks.

Inclusion Criteria

My radiation therapy plan includes a CBCT scan for treatment guidance.

I am undergoing radiation therapy for cancer in my head, neck, chest, liver, breast, genital organs, or digestive system.

Exclusion Criteria

Patient has a life expectancy <3 months

Patient is pregnant or has plans for pregnancy during the period of treatment

I use a wheelchair for mobility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants undergo radiation treatment using HyperSight CBCT to evaluate image quality and its impact on treatment delivery

9 weeks

Daily visits for radiation treatment

Follow-up

Participants are monitored for safety and effectiveness after radiation treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HyperSight CBCT

Trial Overview The study compares a new CBCT imaging technology called HyperSight to conventional CBCT in terms of image quality. It aims to see if HyperSight can improve the accuracy of radiation treatment delivery by providing clearer images for various tasks beyond patient positioning.

How Is the Trial Designed?

Group I: HyperSight Imaging Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Published Research Related to This Trial

Contrast-enhanced cone beam CT (CE-CBCT) is effective in distinguishing between benign and malignant breast lesions, with the best discrimination occurring 1 minute after contrast administration, achieving 69% sensitivity and 69.2% specificity.

CE-CBCT can also differentiate between breast cancer subtypes, showing the lowest enhancement for triple-negative lesions, indicating its potential for more tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal acquisition time to discriminate between breast cancer subtypes with contrast-enhanced cone-beam CT. Chen, JT., Zhou, CY., He, N., et al.[2021]

The HyperSight cone beam computed tomography (CBCT) system significantly reduces image artifacts compared to the standard TrueBeam system, providing image quality comparable to fan beam CT (CTsim) in just 6 seconds of acquisition time.

HyperSight breath hold imaging (HSBH) offers improved image uniformity and a contrast-to-noise ratio over free breathing imaging, making it a valuable tool for accurate dose calculations in adaptive radiation therapy workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Technology Allowing Cone Beam Computed Tomography in 6 Seconds: A Patient Study of Comparative Image Quality. Robar, JL., Cherpak, A., MacDonald, RL., et al.[2023]

In a study involving 20 breast cancer patients, cone-beam computed tomography (CBCT) was found to significantly reduce setup uncertainties compared to electronic portal imaging devices (EPID), with EPID underestimating setup errors by 20% to 50%.

The analysis revealed that while both imaging methods showed differences in measuring setup errors, CBCT provided more accurate measurements of bony anatomy, leading to better alignment during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast patient setup error assessment: comparison of electronic portal image devices and cone-beam computed tomography matching results. Topolnjak, R., Sonke, JJ., Nijkamp, J., et al.[2022]

A study using a multi-purpose body phantom to simulate lung tumor motion found that the imaging dose had minimal impact on the visibility of the internal target volume (ITV) in free-breathing CBCT images, regardless of breathing patterns.

The results suggest that low-dose FBCBCT can be effectively used in clinical settings, providing adequate image quality while significantly reducing radiation exposure to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-J-08: Dependence of Imaging Dose on Image Quality of Free-Breathing 3DCBCT of Moving Tumors. Kauweloa, K., Park, J., Song, W.[2019]

Using specific kV-CBCT protocols can significantly reduce imaging doses to normal tissues during radiotherapy, with reductions of up to 50% observed in certain protocols like Fast and Low Dose modes for Pelvis and Head imaging.

The study highlights the importance of selecting appropriate imaging protocols to minimize radiation exposure, which can help lower the risk of secondary cancers while still maintaining adequate image quality for treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging doses for different CBCT protocols on the Halcyon 3.0 linear accelerator - TLD measurements in an anthropomorphic phantom. Altergot, A., Schürmann, M., Jungert, T., et al.[2023]

Standard cone-beam computed tomography (CBCT) scans generally expose both adult and child phantoms to higher radiation doses compared to panoramic and lateral cephalometric radiographs, even with shielding and smaller fields of view.

However, using shielded low-dose CBCT protocols can significantly reduce radiation exposure, making them safer alternatives to conventional radiographs, especially when high resolution is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can modifying shielding, field of view, and exposure settings make the effective dose of a cone-beam computed tomography comparable to traditional radiographs used for orthodontic diagnosis? Ting, S., Attaia, D., Johnson, KB., et al.[2021]

Short-scan configurations in cone-beam CT (CBCT) for head-neck-cancer image-guided radiation therapy (IGRT) can reduce imaging time and dose while still providing adequate image quality, but the quality varies based on exposure levels and the number of views used.

The study found that iterative reconstruction algorithms based on total-variation (TV) minimization are more robust to varying data conditions compared to conventional filtered-backprojection (FBP) methods, suggesting that TV algorithms may be preferable for optimizing image quality in different scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of cone-beam CT image quality trade-off for image-guided radiation therapy. Bian, J., Sharp, GC., Park, YK., et al.[2016]

In a review of 427 orthodontic CBCT scans, 842 incidental findings were identified, averaging 1.97 findings per scan, with the majority occurring in the airway (42.3%) and paranasal sinuses (30.9%).

Most incidental findings (85.3%) were non-odontogenic, highlighting the importance for dental clinicians to thoroughly review and document all findings, as many are outside their typical areas of focus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The frequency and nature of incidental findings in large-field cone beam computed tomography scans of an orthodontic sample. Edwards, R., Alsufyani, N., Heo, G., et al.[2022]

A total of 10,348 cone-beam computed tomography (CBCT) scans were analyzed, revealing that 99.7% were performed with small to medium field of view (FOV), which is important for minimizing radiation exposure, especially in younger patients.

The study highlighted that while some radiation protection measures were applied, such as reducing FOV and scan angle, these practices were not consistently followed, indicating a need for improved adherence to safety protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBCTs in a Swiss university dental clinic: a retrospective evaluation over 5 years with emphasis on radiation protection criteria. Klingler, S., Biel, P., Tschanz, M., et al.[2023]

Using cone beam computed tomography (CBCT) imaging in the first week of radiotherapy allows for the creation of a patient-specific planning target volume (PTV), which can lead to more precise treatment targeting.

The adaptive radiotherapy plan significantly reduced radiation exposure to the lungs and heart, with the lung dose decreasing from 15.6 Gy to 10.2 Gy and the heart mean dose from 26.9 Gy to 20.7 Gy, demonstrating improved safety for patients undergoing treatment for esophageal carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cone beam computed tomography-derived adaptive radiotherapy for radical treatment of esophageal cancer. Hawkins, MA., Brooks, C., Hansen, VN., et al.[2016]

In a study of 162 CBCT examinations involving 134 patients, it was found that patient movement of 3 mm or more significantly decreased the quality and interpretability of the images, increasing the likelihood of images being deemed 'not interpretable.'

The presence of metal or radiopaque materials in the field-of-view also negatively impacted image quality, indicating that both patient movement and materials can compromise the effectiveness of CBCT imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient movement characteristics and the impact on CBCT image quality and interpretability. Spin-Neto, R., Costa, C., Salgado, DM., et al.[2022]

C-arm cone-beam computed tomography (CBCT) is a cutting-edge imaging technology that enhances interventional oncology by providing detailed cross-sectional images, which can improve treatment planning and navigation.

The integration of CBCT in angiographic systems allows for more precise loco-regional oncological treatments, potentially leading to better patient outcomes in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

C-arm cone-beam computed tomography in interventional oncology: technical aspects and clinical applications. Floridi, C., Radaelli, A., Abi-Jaoudeh, N., et al.[2021]

Cone beam computed tomography (CBCT) is increasingly used in dental practice for its ability to produce high-quality, accurate 3D images of the maxillofacial skeleton, enhancing diagnostic capabilities.

The article emphasizes the importance of understanding patient radiation exposure associated with CBCT and highlights its appropriate clinical applications to ensure safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essentials of maxillofacial cone beam computed tomography. Scarfe, WC., Farman, AG., Levin, MD., et al.[2022]

The modified CBCT scan protocol (MHNS20) resulted in lower radiation doses to critical areas, such as the left optical lens, compared to the standard protocol (HNS20), suggesting improved safety for patients undergoing radiation therapy for head and neck cancer.

Image registration results showed that the MHNS20 protocol maintained accuracy in treatment positioning, with 100% of procedures within a 3 mm threshold in the superior/inferior direction, indicating its efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Investigation of the Feasibility and Utility of a Low-dose Cone-beam Computed Tomography Scan Protocol for Head and Neck Cancer Patients. Turner, A., McGuffin, M., Au, P.[2019]

Reducing the radiographic field of view (FOV) in cone beam computed tomography (CBCT) does not enhance the accuracy of implant planning for single posterior missing teeth, suggesting that a full arch view may be unnecessary in these cases.

However, caution is advised when using a reduced FOV in scenarios with multiple missing teeth or radiographic artifacts, as these conditions can lead to significant discrepancies in alignment, particularly with maximum deviations observed up to 1.44 mm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of radiographic field-of-view volume on alignment accuracy during virtual implant planning: A noninterventional retrospective pilot study. Pieralli, S., Beyer, C., Wesemann, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12419991/

Feasibility of HyperSight CBCT for adaptive radiation therapy In this study, the accuracy of dose calculations performed on HyperSight CBCT was found to be within 1% of CTsim calculations for pelvic and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023002953

Novel Technology Allowing Cone Beam Computed ... The HyperSight system provides 6-second CBCT acquisition with image artifacts that are significantly reduced compared with TrueBeam and comparable to those in ...

3. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00244-6/fulltext

Comprehensive Image Quality Evaluation and Motion ... This evaluation shows significant image improvement of HyperSight CBCT over conventional CBCT on image contrast, HU constancy, and noise level ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02730-8

Advanced HyperSight™ imaging for patients with adaptive ... This study evaluated the longitudinal image quality of the novel HyperSightTM-CBCT (hCBCT) compared to planning CT (pCT), using phantoms and ...

5. nature.com nature.com/articles/s41598-025-99920-x

CBCT based radiomic features in patients with CT guided ... This study comprehensively evaluates the stability of radiomic features, as potential imaging biomarkers, in pelvic structures of prostate cancer patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12529831/

Advanced HyperSight™ imaging for patients with adaptive ... This study evaluated the longitudinal image quality of the novel HyperSightTM-CBCT (hCBCT) compared to planning CT (pCT), using phantoms and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1120179725002017

Evaluation of the dosimetric accuracy of HyperSight CBCT ... HyperSight CBCT images reconstructed with Acuros algorithm provide HU accuracy and dosimetric performance comparable to planning CT. Our clinical evaluation ...

8. varian.com varian.com/products/radiotherapy/treatment-delivery/hypersight

HyperSight Larger images. Better contrast. Faster CBCT imaging.Welcome to HyperSight ... Important Safety Notice: Varian products used to treat cancer and other ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06681233

Feasibility Study of CBCT for IGRT in Cancer Patients This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can ...