HyperSight CBCT Imaging for Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Varian, a Siemens Healthineers Company

Disqualifiers: ECOG ≥3, Wheelchair bound, Life expectancy <3 months, Pregnant, Vulnerable populations, others

No Placebo Group

Trial Summary

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.

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}

Research Team

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 18 years old or older.

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.

Trial 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 (Imaging Technology)

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

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]