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

Trial Summary

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 data supports the effectiveness of the treatment HyperSight CBCT Imaging for Cancer?

Research shows that cone-beam computed tomography (CBCT) can help improve the accuracy of radiation therapy by better targeting the cancerous area, as seen in studies with esophageal and head-neck cancers. This suggests that HyperSight CBCT might also be effective in improving cancer treatment by reducing exposure to healthy tissues. ^{1 2 3 4 5}

Is HyperSight CBCT imaging safe for humans?

Research on cone-beam computed tomography (CBCT) shows that while it is useful for precise imaging, it does expose patients to radiation, which can increase the risk of secondary cancer. Efforts are being made to reduce this radiation exposure through modified protocols and shielding. ^{6 7 8 9 10}

How is HyperSight CBCT Imaging different from other cancer treatments?

HyperSight CBCT Imaging is unique because it offers rapid imaging in just 6 seconds with enhanced image quality, which helps in better visualization and treatment planning for cancer compared to traditional imaging methods. This technology allows for more precise targeting of tumors during treatment, potentially improving outcomes. ^{11 12 13 14 15}

What is the purpose of this trial?

Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow. Varian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image. 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 improve the process of delivering radiation treatments. The goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan.

Eligibility Criteria

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

I use a wheelchair for mobility.

Patient has a life expectancy <3 months

I need help with my daily activities due to my health condition.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Breast patient setup error assessment: comparison of electronic portal image devices and cone-beam computed tomography matching results. [2022]

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

Cone beam computed tomography-derived adaptive radiotherapy for radical treatment of esophageal cancer. [2016]

3. Denmark pubmed.ncbi.nlm.nih.gov

Impact of radiographic field-of-view volume on alignment accuracy during virtual implant planning: A noninterventional retrospective pilot study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Patient movement characteristics and the impact on CBCT image quality and interpretability. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Investigation of cone-beam CT image quality trade-off for image-guided radiation therapy. [2016]

6. United States 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? [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Imaging doses for different CBCT protocols on the Halcyon 3.0 linear accelerator - TLD measurements in an anthropomorphic phantom. [2023]

8. United States 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. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

The frequency and nature of incidental findings in large-field cone beam computed tomography scans of an orthodontic sample. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

CBCTs in a Swiss university dental clinic: a retrospective evaluation over 5 years with emphasis on radiation protection criteria. [2023]

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

Novel Technology Allowing Cone Beam Computed Tomography in 6 Seconds: A Patient Study of Comparative Image Quality. [2023]

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

SU-E-J-08: Dependence of Imaging Dose on Image Quality of Free-Breathing 3DCBCT of Moving Tumors. [2019]

13. France pubmed.ncbi.nlm.nih.gov

Optimal acquisition time to discriminate between breast cancer subtypes with contrast-enhanced cone-beam CT. [2021]

14. Italy pubmed.ncbi.nlm.nih.gov

C-arm cone-beam computed tomography in interventional oncology: technical aspects and clinical applications. [2021]

15. Canada pubmed.ncbi.nlm.nih.gov

Essentials of maxillofacial cone beam computed tomography. [2022]